Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2011-2016

ABSTRACT

Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting children and adults. The most frequent symptoms are swallowing difficulties and thoracic pain. The disease has first been described in the 1980s and is found with rapidly increasing frequency mainly in industrialized countries. The factors that lead to EoE are until now incompletely understood, of importance, the disease is found more frequently in men and patients suffering from allergic diseases (e.g., Asthma). So far there exists no activity index to define the severity of EoE; such an index is urgently needed for future clinical trials to determine the efficacy of current and future therapies. The investigators' 3-year project, carried out in cooperation with international EoE experts, aims at the development of an activity index for adult and pediatric EoE patients that will be used in future clinical trials as well as observational studies. Detailed Description Background: 1. Introduction Coordinated by the Swiss Eosinophilic Esophagitis Research Group and in close collaboration with The International Gastrointestinal Eosinophil Researchers (TIGERS), we plan to conduct a series of related studies in order to develop an Activity Index (AI) for adult and pediatric patients with Eosinophilic Esophagitis (EoE). EoE is an emerging disease, with rapidly growing clinical relevance and research activities. A validated assessment instrument is therefore urgently needed. The purpose of this project is to develop within a representative group of pediatric and adult EoE-experienced gastroenterologists and EoE-experienced pathologists an AI for this chronic inflammatory esophageal disease. The project is investigator initiated, but funding from different sources will be necessary. The project will be conducted in compliance with this protocol, with the ICH guideline E6 on Good Clinical Practice, the FDA perspectives on patient-reported outcomes to support medical product labeling claims (1,2), and the applicable regulatory requirements. As EoE is a new disorder we include below a comprehensive description of the disease. 1.1. Characterization of Eosinophilic Esophagitis Definition: EoE is rapidly emerging as a distinctive disorder in pediatric and adult gastroenterology. EoE is a chronic-inflammatory esophageal disease, characterized clinicopathologically by the presence of esophagus-related symptoms and by a dense esophageal eosinophilia, both of which persist despite prolonged treatment with proton pump inhibitors (3). Epidemiology: EoE is diagnosed 2-3 times more frequently in males than in females. The disease is found mainly in industrialized countries such as the United States, Canada, Europe and Australia. EoE is likely to be a 'young' disease: it had not been seen prior to the early 1980, and there is strong evidence to suggest that its prevalence is increasing (4)(5). A population-based study performed in Switzerland suggested an increase in prevalence from 2 per 100000 to 40 per 100000 inhabitants over a 19-year period (6). Clinical Symptoms: As in many other diseases, symptom presentation differs significantly between children and adults. In infants and toddlers, food refusal is a common symptom of EoE. Children often suffer from GERD-like symptoms, vomiting and abdominal pain. Dysphagia and food impaction are reported increasingly with proceeding age. Adolescents and adults present mostly with dysphagia for solids and food impaction (5-7). Endoscopy/Histology: Esophago-gastro-duodenoscopy (EGD) is the first diagnostic step in the evaluation of an individual with suspected EoE. A broad spectrum of endoscopic features associated with EoE have been described, but the endoscopic suspicion needs confirmation by histology. The key diagnostic criterion for diagnosing EoE is an increased number of intraepithelial eosinophils in patients with lack of responsiveness to high-dose proton pump inhibition or normal pH-monitoring of the distal esophagus. In a consensus conference a cut-off value of =15 Eos/HPF (peak eosinophilic count in 400 fold magnification) in any biopsy was recommended as diagnostic criterion (3). Treatment: The optimal treatment for EoE is not yet clear, as experience has been limited largely to case series and small controlled trials. So far topically and systemically administered corticosteroids, several types of allergen-reduced diets, immunosuppressants and IL-5 blocking agents have been shown to be efficacious (8-11). 1.2. Rationale for the planned Studies In the clinical setting the current status of a given disease is often reported as "mild", "moderate" and "severe", and the course of the disease over time is described with terms such as "stable", "progressive", "in remission" or "flare-up". None of these terms has so far been clearly defined for EoE. However, an increasing number of phase 3 therapeutic multi-center trials and natural history studies in patients with EoE will be performed in the near future. In order to set up standardized study protocols and to compare results between different studies a standardized definition of disease activity is a necessity. Taken together, for clinical and for research purposes it is indispensable to define the terms mentioned above by a suitable, reproducible and validated score, which reflects the disease activity as precisely as possible. The necessity for such a score has repeatedly been discussed by the TIGERS and has been underscored by several publications (12). Objective The planned research program has the aim to develop and validate an AI for EoE (EEsAI) for adult (adEEsAI) and pediatric (pedEEsAI) patients, which can be used in future clinical trials and observational studies. According to the characterization of EoE, the AI will likely contain clinical and histopathological items. Laboratory and endoscopical parameters may be part of the score, but in a subsidiary role. Methods: The development and validation of a disease activity index is a research program involving several related studies. Broadly speaking, it involves 3 main steps: Step I Item Generation and Reduction through a Delphi process with an international expert group (Development phase A). Step II Item Weighting and Activity Index Derivation, using data from a first cohort of adult and a first cohort of pediatric patients (Development phase B). Step III Evaluation of the Activity Index using data from a second independent cohort of adult and pediatric patients respectively. This involves also assessment of test-retest reliability and responsiveness of the score, using longitudinal data from the same patients. More... »

URL

https://clinicaltrials.gov/show/NCT00939263

Related SciGraph Publications

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting children and adults. The most frequent symptoms are swallowing difficulties and thoracic pain. The disease has first been described in the 1980s and is found with rapidly increasing frequency mainly in industrialized countries. The factors that lead to EoE are until now incompletely understood, of importance, the disease is found more frequently in men and patients suffering from allergic diseases (e.g., Asthma). So far there exists no activity index to define the severity of EoE; such an index is urgently needed for future clinical trials to determine the efficacy of current and future therapies. The investigators' 3-year project, carried out in cooperation with international EoE experts, aims at the development of an activity index for adult and pediatric EoE patients that will be used in future clinical trials as well as observational studies.\n\nDetailed Description\nBackground: 1. Introduction Coordinated by the Swiss Eosinophilic Esophagitis Research Group and in close collaboration with The International Gastrointestinal Eosinophil Researchers (TIGERS), we plan to conduct a series of related studies in order to develop an Activity Index (AI) for adult and pediatric patients with Eosinophilic Esophagitis (EoE). EoE is an emerging disease, with rapidly growing clinical relevance and research activities. A validated assessment instrument is therefore urgently needed. The purpose of this project is to develop within a representative group of pediatric and adult EoE-experienced gastroenterologists and EoE-experienced pathologists an AI for this chronic inflammatory esophageal disease. The project is investigator initiated, but funding from different sources will be necessary. The project will be conducted in compliance with this protocol, with the ICH guideline E6 on Good Clinical Practice, the FDA perspectives on patient-reported outcomes to support medical product labeling claims (1,2), and the applicable regulatory requirements. As EoE is a new disorder we include below a comprehensive description of the disease. 1.1. Characterization of Eosinophilic Esophagitis Definition: EoE is rapidly emerging as a distinctive disorder in pediatric and adult gastroenterology. EoE is a chronic-inflammatory esophageal disease, characterized clinicopathologically by the presence of esophagus-related symptoms and by a dense esophageal eosinophilia, both of which persist despite prolonged treatment with proton pump inhibitors (3). Epidemiology: EoE is diagnosed 2-3 times more frequently in males than in females. The disease is found mainly in industrialized countries such as the United States, Canada, Europe and Australia. EoE is likely to be a 'young' disease: it had not been seen prior to the early 1980, and there is strong evidence to suggest that its prevalence is increasing (4)(5). A population-based study performed in Switzerland suggested an increase in prevalence from 2 per 100000 to 40 per 100000 inhabitants over a 19-year period (6). Clinical Symptoms: As in many other diseases, symptom presentation differs significantly between children and adults. In infants and toddlers, food refusal is a common symptom of EoE. Children often suffer from GERD-like symptoms, vomiting and abdominal pain. Dysphagia and food impaction are reported increasingly with proceeding age. Adolescents and adults present mostly with dysphagia for solids and food impaction (5-7). Endoscopy/Histology: Esophago-gastro-duodenoscopy (EGD) is the first diagnostic step in the evaluation of an individual with suspected EoE. A broad spectrum of endoscopic features associated with EoE have been described, but the endoscopic suspicion needs confirmation by histology. The key diagnostic criterion for diagnosing EoE is an increased number of intraepithelial eosinophils in patients with lack of responsiveness to high-dose proton pump inhibition or normal pH-monitoring of the distal esophagus. In a consensus conference a cut-off value of =15 Eos/HPF (peak eosinophilic count in 400 fold magnification) in any biopsy was recommended as diagnostic criterion (3). Treatment: The optimal treatment for EoE is not yet clear, as experience has been limited largely to case series and small controlled trials. So far topically and systemically administered corticosteroids, several types of allergen-reduced diets, immunosuppressants and IL-5 blocking agents have been shown to be efficacious (8-11). 1.2. Rationale for the planned Studies In the clinical setting the current status of a given disease is often reported as \"mild\", \"moderate\" and \"severe\", and the course of the disease over time is described with terms such as \"stable\", \"progressive\", \"in remission\" or \"flare-up\". None of these terms has so far been clearly defined for EoE. However, an increasing number of phase 3 therapeutic multi-center trials and natural history studies in patients with EoE will be performed in the near future. In order to set up standardized study protocols and to compare results between different studies a standardized definition of disease activity is a necessity. Taken together, for clinical and for research purposes it is indispensable to define the terms mentioned above by a suitable, reproducible and validated score, which reflects the disease activity as precisely as possible. The necessity for such a score has repeatedly been discussed by the TIGERS and has been underscored by several publications (12). Objective The planned research program has the aim to develop and validate an AI for EoE (EEsAI) for adult (adEEsAI) and pediatric (pedEEsAI) patients, which can be used in future clinical trials and observational studies. According to the characterization of EoE, the AI will likely contain clinical and histopathological items. Laboratory and endoscopical parameters may be part of the score, but in a subsidiary role. Methods: The development and validation of a disease activity index is a research program involving several related studies. Broadly speaking, it involves 3 main steps: Step I Item Generation and Reduction through a Delphi process with an international expert group (Development phase A). Step II Item Weighting and Activity Index Derivation, using data from a first cohort of adult and a first cohort of pediatric patients (Development phase B). Step III Evaluation of the Activity Index using data from a second independent cohort of adult and pediatric patients respectively. This involves also assessment of test-retest reliability and responsiveness of the score, using longitudinal data from the same patients.", 
    "endDate": "2016-12-01T00:00:00Z", 
    "id": "sg:clinicaltrial.NCT00939263", 
    "keywords": [
      "development", 
      "validation", 
      "eosinophilic esophagitis", 
      "multicenter study", 
      "EoE", 
      "chronic inflammatory disease", 
      "esophagus", 
      "child", 
      "adult", 
      "symptom", 
      "pain", 
      "disease", 
      "frequency", 
      "developed country", 
      "men", 
      "patient", 
      "allergic disease", 
      "asthma", 
      "index", 
      "severity", 
      "future clinical trial", 
      "efficacy", 
      "future therapy", 
      "cooperation", 
      "International", 
      "pediatrics", 
      "observational study", 
      "introduction", 
      "tiger", 
      "related study", 
      "adult and pediatric patient", 
      "clinical relevance", 
      "Research", 
      "assessment instrument", 
      "representative group", 
      "gastroenterologist", 
      "pathologist", 
      "esophageal disease", 
      "different source", 
      "compliance", 
      "protocol", 
      "guideline", 
      "Good Clinical Practice", 
      "FDA", 
      "patient-reported outcome", 
      "medical product", 
      "regulatory requirement", 
      "disorder", 
      "comprehensive description", 
      "gastroenterology", 
      "related symptom", 
      "eosinophilia", 
      "prolonged treatment", 
      "proton", 
      "inhibitor", 
      "epidemiology", 
      "male", 
      "female", 
      "United State", 
      "Canada", 
      "Europe and Australia", 
      "strong evidence", 
      "prevalence", 
      "population-based study", 
      "Switzerland", 
      "inhabitant", 
      "period", 
      "clinical symptom", 
      "symptom presentation", 
      "infant", 
      "toddler", 
      "food", 
      "common symptom", 
      "vomiting", 
      "abdominal pain", 
      "Deglutition Disorder", 
      "impaction", 
      "age", 
      "Adolescent", 
      "solid", 
      "diagnostics", 
      "Evaluation Study as Topic", 
      "broad spectrum", 
      "feature", 
      "suspicion", 
      "confirmation", 
      "histology", 
      "diagnostic criterion", 
      "diagnosing", 
      "increased number", 
      "eosinophil", 
      "responsiveness", 
      "high dose", 
      "inhibition", 
      "normal pH", 
      "distal esophagus", 
      "consensus conference", 
      "cut", 
      "count", 
      "magnification", 
      "biopsy", 
      "optimal treatment", 
      "case series", 
      "controlled trial", 
      "corticosteroid", 
      "allergen", 
      "immunosuppressant", 
      "IL", 
      "agent", 
      "rationale", 
      "planned study", 
      "clinical setting", 
      "current status", 
      "given disease", 
      "remission", 
      "flare-up", 
      "multi-center trial", 
      "natural history study", 
      "study protocol", 
      "different study", 
      "definition", 
      "disease activity", 
      "necessity", 
      "research purpose", 
      "score", 
      "publication", 
      "planned research program", 
      "laboratory", 
      "parameter", 
      "subsidiary", 
      "method", 
      "research program", 
      "main step", 
      "generation", 
      "Delphi", 
      "international expert", 
      "development phase", 
      "derivation", 
      "first cohort", 
      "pediatric patient", 
      "independent cohort", 
      "assessment", 
      "test-retest reliability", 
      "longitudinal data", 
      "same patient"
    ], 
    "name": "Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT00939263"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2019-03-07T15:23", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "file:///pack/app/us_ct_data_00007.json", 
    "sponsor": [
      {
        "id": "https://www.grid.ac/institutes/grid.430503.1", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.59734.3c", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.257413.6", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.241116.1", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.239552.a", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.38142.3c", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.413354.4", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.416512.5", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.411656.1", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.412353.2", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.417468.8", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.67033.31", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.25073.33", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.411377.7", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.16753.36", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.5734.5", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.413808.6", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.417467.7", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.421912.d", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.261870.a", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.14848.31", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.8515.9", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.24827.3b", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.414079.f", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.477516.6", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.66875.3a", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.266100.3", 
        "type": "Organization"
      }
    ], 
    "startDate": "2011-01-01T00:00:00Z", 
    "subjectOf": [
      {
        "id": "https://doi.org/10.1053/j.gastro.2003.09.024", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1000840555"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/apt.13370", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1007946560"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jaci.2004.11.006", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009573130"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1053/j.gastro.2015.11.004", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014198964"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejm200408263510924", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1017729012"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/0895-4356(89)90128-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1019033097"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1053/j.gastro.2007.08.017", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1027811887"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s1542-3565(05)00885-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1047218912"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1053/j.gastro.2014.08.028", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1047866426"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1524-4733.2007.00275.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1049954810"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1477-7525-4-79", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1050813769", 
          "https://doi.org/10.1186/1477-7525-4-79"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT00939263"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/clinicaltrial.NCT00939263'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT00939263'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT00939263'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT00939263'


 

This table displays all metadata directly associated to this object as RDF triples.

250 TRIPLES      16 PREDICATES      197 URIs      154 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT00939263 schema:about anzsrc-for:3053
2 schema:description Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting children and adults. The most frequent symptoms are swallowing difficulties and thoracic pain. The disease has first been described in the 1980s and is found with rapidly increasing frequency mainly in industrialized countries. The factors that lead to EoE are until now incompletely understood, of importance, the disease is found more frequently in men and patients suffering from allergic diseases (e.g., Asthma). So far there exists no activity index to define the severity of EoE; such an index is urgently needed for future clinical trials to determine the efficacy of current and future therapies. The investigators' 3-year project, carried out in cooperation with international EoE experts, aims at the development of an activity index for adult and pediatric EoE patients that will be used in future clinical trials as well as observational studies. Detailed Description Background: 1. Introduction Coordinated by the Swiss Eosinophilic Esophagitis Research Group and in close collaboration with The International Gastrointestinal Eosinophil Researchers (TIGERS), we plan to conduct a series of related studies in order to develop an Activity Index (AI) for adult and pediatric patients with Eosinophilic Esophagitis (EoE). EoE is an emerging disease, with rapidly growing clinical relevance and research activities. A validated assessment instrument is therefore urgently needed. The purpose of this project is to develop within a representative group of pediatric and adult EoE-experienced gastroenterologists and EoE-experienced pathologists an AI for this chronic inflammatory esophageal disease. The project is investigator initiated, but funding from different sources will be necessary. The project will be conducted in compliance with this protocol, with the ICH guideline E6 on Good Clinical Practice, the FDA perspectives on patient-reported outcomes to support medical product labeling claims (1,2), and the applicable regulatory requirements. As EoE is a new disorder we include below a comprehensive description of the disease. 1.1. Characterization of Eosinophilic Esophagitis Definition: EoE is rapidly emerging as a distinctive disorder in pediatric and adult gastroenterology. EoE is a chronic-inflammatory esophageal disease, characterized clinicopathologically by the presence of esophagus-related symptoms and by a dense esophageal eosinophilia, both of which persist despite prolonged treatment with proton pump inhibitors (3). Epidemiology: EoE is diagnosed 2-3 times more frequently in males than in females. The disease is found mainly in industrialized countries such as the United States, Canada, Europe and Australia. EoE is likely to be a 'young' disease: it had not been seen prior to the early 1980, and there is strong evidence to suggest that its prevalence is increasing (4)(5). A population-based study performed in Switzerland suggested an increase in prevalence from 2 per 100000 to 40 per 100000 inhabitants over a 19-year period (6). Clinical Symptoms: As in many other diseases, symptom presentation differs significantly between children and adults. In infants and toddlers, food refusal is a common symptom of EoE. Children often suffer from GERD-like symptoms, vomiting and abdominal pain. Dysphagia and food impaction are reported increasingly with proceeding age. Adolescents and adults present mostly with dysphagia for solids and food impaction (5-7). Endoscopy/Histology: Esophago-gastro-duodenoscopy (EGD) is the first diagnostic step in the evaluation of an individual with suspected EoE. A broad spectrum of endoscopic features associated with EoE have been described, but the endoscopic suspicion needs confirmation by histology. The key diagnostic criterion for diagnosing EoE is an increased number of intraepithelial eosinophils in patients with lack of responsiveness to high-dose proton pump inhibition or normal pH-monitoring of the distal esophagus. In a consensus conference a cut-off value of =15 Eos/HPF (peak eosinophilic count in 400 fold magnification) in any biopsy was recommended as diagnostic criterion (3). Treatment: The optimal treatment for EoE is not yet clear, as experience has been limited largely to case series and small controlled trials. So far topically and systemically administered corticosteroids, several types of allergen-reduced diets, immunosuppressants and IL-5 blocking agents have been shown to be efficacious (8-11). 1.2. Rationale for the planned Studies In the clinical setting the current status of a given disease is often reported as "mild", "moderate" and "severe", and the course of the disease over time is described with terms such as "stable", "progressive", "in remission" or "flare-up". None of these terms has so far been clearly defined for EoE. However, an increasing number of phase 3 therapeutic multi-center trials and natural history studies in patients with EoE will be performed in the near future. In order to set up standardized study protocols and to compare results between different studies a standardized definition of disease activity is a necessity. Taken together, for clinical and for research purposes it is indispensable to define the terms mentioned above by a suitable, reproducible and validated score, which reflects the disease activity as precisely as possible. The necessity for such a score has repeatedly been discussed by the TIGERS and has been underscored by several publications (12). Objective The planned research program has the aim to develop and validate an AI for EoE (EEsAI) for adult (adEEsAI) and pediatric (pedEEsAI) patients, which can be used in future clinical trials and observational studies. According to the characterization of EoE, the AI will likely contain clinical and histopathological items. Laboratory and endoscopical parameters may be part of the score, but in a subsidiary role. Methods: The development and validation of a disease activity index is a research program involving several related studies. Broadly speaking, it involves 3 main steps: Step I Item Generation and Reduction through a Delphi process with an international expert group (Development phase A). Step II Item Weighting and Activity Index Derivation, using data from a first cohort of adult and a first cohort of pediatric patients (Development phase B). Step III Evaluation of the Activity Index using data from a second independent cohort of adult and pediatric patients respectively. This involves also assessment of test-retest reliability and responsiveness of the score, using longitudinal data from the same patients.
3 schema:endDate 2016-12-01T00:00:00Z
4 schema:keywords Adolescent
5 Canada
6 Deglutition Disorder
7 Delphi
8 EoE
9 Europe and Australia
10 Evaluation Study as Topic
11 FDA
12 Good Clinical Practice
13 IL
14 International
15 Research
16 Switzerland
17 United State
18 abdominal pain
19 adult
20 adult and pediatric patient
21 age
22 agent
23 allergen
24 allergic disease
25 assessment
26 assessment instrument
27 asthma
28 biopsy
29 broad spectrum
30 case series
31 child
32 chronic inflammatory disease
33 clinical relevance
34 clinical setting
35 clinical symptom
36 common symptom
37 compliance
38 comprehensive description
39 confirmation
40 consensus conference
41 controlled trial
42 cooperation
43 corticosteroid
44 count
45 current status
46 cut
47 definition
48 derivation
49 developed country
50 development
51 development phase
52 diagnosing
53 diagnostic criterion
54 diagnostics
55 different source
56 different study
57 disease
58 disease activity
59 disorder
60 distal esophagus
61 efficacy
62 eosinophil
63 eosinophilia
64 eosinophilic esophagitis
65 epidemiology
66 esophageal disease
67 esophagus
68 feature
69 female
70 first cohort
71 flare-up
72 food
73 frequency
74 future clinical trial
75 future therapy
76 gastroenterologist
77 gastroenterology
78 generation
79 given disease
80 guideline
81 high dose
82 histology
83 immunosuppressant
84 impaction
85 increased number
86 independent cohort
87 index
88 infant
89 inhabitant
90 inhibition
91 inhibitor
92 international expert
93 introduction
94 laboratory
95 longitudinal data
96 magnification
97 main step
98 male
99 medical product
100 men
101 method
102 multi-center trial
103 multicenter study
104 natural history study
105 necessity
106 normal pH
107 observational study
108 optimal treatment
109 pain
110 parameter
111 pathologist
112 patient
113 patient-reported outcome
114 pediatric patient
115 pediatrics
116 period
117 planned research program
118 planned study
119 population-based study
120 prevalence
121 prolonged treatment
122 protocol
123 proton
124 publication
125 rationale
126 regulatory requirement
127 related study
128 related symptom
129 remission
130 representative group
131 research program
132 research purpose
133 responsiveness
134 same patient
135 score
136 severity
137 solid
138 strong evidence
139 study protocol
140 subsidiary
141 suspicion
142 symptom
143 symptom presentation
144 test-retest reliability
145 tiger
146 toddler
147 validation
148 vomiting
149 schema:name Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study
150 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT00939263
151 schema:sdDatePublished 2019-03-07T15:23
152 schema:sdLicense https://scigraph.springernature.com/explorer/license/
153 schema:sdPublisher N591ee2c7aca846ee9e69e531a4b72c22
154 schema:sponsor https://www.grid.ac/institutes/grid.14848.31
155 https://www.grid.ac/institutes/grid.16753.36
156 https://www.grid.ac/institutes/grid.239552.a
157 https://www.grid.ac/institutes/grid.241116.1
158 https://www.grid.ac/institutes/grid.24827.3b
159 https://www.grid.ac/institutes/grid.25073.33
160 https://www.grid.ac/institutes/grid.257413.6
161 https://www.grid.ac/institutes/grid.261870.a
162 https://www.grid.ac/institutes/grid.266100.3
163 https://www.grid.ac/institutes/grid.38142.3c
164 https://www.grid.ac/institutes/grid.411377.7
165 https://www.grid.ac/institutes/grid.411656.1
166 https://www.grid.ac/institutes/grid.412353.2
167 https://www.grid.ac/institutes/grid.413354.4
168 https://www.grid.ac/institutes/grid.413808.6
169 https://www.grid.ac/institutes/grid.414079.f
170 https://www.grid.ac/institutes/grid.416512.5
171 https://www.grid.ac/institutes/grid.417467.7
172 https://www.grid.ac/institutes/grid.417468.8
173 https://www.grid.ac/institutes/grid.421912.d
174 https://www.grid.ac/institutes/grid.430503.1
175 https://www.grid.ac/institutes/grid.477516.6
176 https://www.grid.ac/institutes/grid.5734.5
177 https://www.grid.ac/institutes/grid.59734.3c
178 https://www.grid.ac/institutes/grid.66875.3a
179 https://www.grid.ac/institutes/grid.67033.31
180 https://www.grid.ac/institutes/grid.8515.9
181 schema:startDate 2011-01-01T00:00:00Z
182 schema:subjectOf sg:pub.10.1186/1477-7525-4-79
183 https://doi.org/10.1016/0895-4356(89)90128-5
184 https://doi.org/10.1016/j.jaci.2004.11.006
185 https://doi.org/10.1016/s1542-3565(05)00885-2
186 https://doi.org/10.1053/j.gastro.2003.09.024
187 https://doi.org/10.1053/j.gastro.2007.08.017
188 https://doi.org/10.1053/j.gastro.2014.08.028
189 https://doi.org/10.1053/j.gastro.2015.11.004
190 https://doi.org/10.1056/nejm200408263510924
191 https://doi.org/10.1111/apt.13370
192 https://doi.org/10.1111/j.1524-4733.2007.00275.x
193 schema:url https://clinicaltrials.gov/show/NCT00939263
194 sgo:license sg:explorer/license/
195 sgo:sdDataset clinical_trials
196 rdf:type schema:MedicalStudy
197 N591ee2c7aca846ee9e69e531a4b72c22 schema:name Springer Nature - SN SciGraph project
198 rdf:type schema:Organization
199 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
200 rdf:type schema:DefinedTerm
201 sg:pub.10.1186/1477-7525-4-79 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050813769
202 https://doi.org/10.1186/1477-7525-4-79
203 rdf:type schema:CreativeWork
204 https://doi.org/10.1016/0895-4356(89)90128-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1019033097
205 rdf:type schema:CreativeWork
206 https://doi.org/10.1016/j.jaci.2004.11.006 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009573130
207 rdf:type schema:CreativeWork
208 https://doi.org/10.1016/s1542-3565(05)00885-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1047218912
209 rdf:type schema:CreativeWork
210 https://doi.org/10.1053/j.gastro.2003.09.024 schema:sameAs https://app.dimensions.ai/details/publication/pub.1000840555
211 rdf:type schema:CreativeWork
212 https://doi.org/10.1053/j.gastro.2007.08.017 schema:sameAs https://app.dimensions.ai/details/publication/pub.1027811887
213 rdf:type schema:CreativeWork
214 https://doi.org/10.1053/j.gastro.2014.08.028 schema:sameAs https://app.dimensions.ai/details/publication/pub.1047866426
215 rdf:type schema:CreativeWork
216 https://doi.org/10.1053/j.gastro.2015.11.004 schema:sameAs https://app.dimensions.ai/details/publication/pub.1014198964
217 rdf:type schema:CreativeWork
218 https://doi.org/10.1056/nejm200408263510924 schema:sameAs https://app.dimensions.ai/details/publication/pub.1017729012
219 rdf:type schema:CreativeWork
220 https://doi.org/10.1111/apt.13370 schema:sameAs https://app.dimensions.ai/details/publication/pub.1007946560
221 rdf:type schema:CreativeWork
222 https://doi.org/10.1111/j.1524-4733.2007.00275.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1049954810
223 rdf:type schema:CreativeWork
224 https://www.grid.ac/institutes/grid.14848.31 schema:Organization
225 https://www.grid.ac/institutes/grid.16753.36 schema:Organization
226 https://www.grid.ac/institutes/grid.239552.a schema:Organization
227 https://www.grid.ac/institutes/grid.241116.1 schema:Organization
228 https://www.grid.ac/institutes/grid.24827.3b schema:Organization
229 https://www.grid.ac/institutes/grid.25073.33 schema:Organization
230 https://www.grid.ac/institutes/grid.257413.6 schema:Organization
231 https://www.grid.ac/institutes/grid.261870.a schema:Organization
232 https://www.grid.ac/institutes/grid.266100.3 schema:Organization
233 https://www.grid.ac/institutes/grid.38142.3c schema:Organization
234 https://www.grid.ac/institutes/grid.411377.7 schema:Organization
235 https://www.grid.ac/institutes/grid.411656.1 schema:Organization
236 https://www.grid.ac/institutes/grid.412353.2 schema:Organization
237 https://www.grid.ac/institutes/grid.413354.4 schema:Organization
238 https://www.grid.ac/institutes/grid.413808.6 schema:Organization
239 https://www.grid.ac/institutes/grid.414079.f schema:Organization
240 https://www.grid.ac/institutes/grid.416512.5 schema:Organization
241 https://www.grid.ac/institutes/grid.417467.7 schema:Organization
242 https://www.grid.ac/institutes/grid.417468.8 schema:Organization
243 https://www.grid.ac/institutes/grid.421912.d schema:Organization
244 https://www.grid.ac/institutes/grid.430503.1 schema:Organization
245 https://www.grid.ac/institutes/grid.477516.6 schema:Organization
246 https://www.grid.ac/institutes/grid.5734.5 schema:Organization
247 https://www.grid.ac/institutes/grid.59734.3c schema:Organization
248 https://www.grid.ac/institutes/grid.66875.3a schema:Organization
249 https://www.grid.ac/institutes/grid.67033.31 schema:Organization
250 https://www.grid.ac/institutes/grid.8515.9 schema:Organization
 




Preview window. Press ESC to close (or click here)


...