Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer: A Pilot Retrospective Multicenter Cohort Study View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2017-2019

ABSTRACT

To conduct a retrospective study to prove a hypothesis of "adjuvant chemotherapy provides survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in high-risk group". This study is a pilot study and the result will be used as a reference for the upcoming prospective randomized controlled trial for same issue including estimating sample size. Two high-volume hospitals (Yonsei University Severance Hospital and Samsung Hospital) will participant this pilot study.FFPE sample blocks and clinical information pertaining to the patients who satisfied with selection criteria will be collected from two institutions. The primary end point of this study is disease-free survival (DFS) that is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined as time from surgery to death by any causes. Clinical information such as age, sex, histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received chemotherapy or not will be centralized.One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from the tissue and the pattern of RNA expression will be evaluated and each sample will be categorized into three risk group (high, intermediate, low risk group) and two predictive group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be delivered to independent statisticians who are responsible to conduct statistical analyses. More... »

URL

https://clinicaltrials.gov/show/NCT03485105

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/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1112", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "To conduct a retrospective study to prove a hypothesis of \"adjuvant chemotherapy provides survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in high-risk group\". This study is a pilot study and the result will be used as a reference for the upcoming prospective randomized controlled trial for same issue including estimating sample size. Two high-volume hospitals (Yonsei University Severance Hospital and Samsung Hospital) will participant this pilot study.FFPE sample blocks and clinical information pertaining to the patients who satisfied with selection criteria will be collected from two institutions. The primary end point of this study is disease-free survival (DFS) that is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined as time from surgery to death by any causes. Clinical information such as age, sex, histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received chemotherapy or not will be centralized.One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from the tissue and the pattern of RNA expression will be evaluated and each sample will be categorized into three risk group (high, intermediate, low risk group) and two predictive group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be delivered to independent statisticians who are responsible to conduct statistical analyses.", 
    "endDate": "2019-11", 
    "id": "sg:clinicaltrial.NCT03485105", 
    "keywords": [
      "disease-free survival", 
      "clinical information", 
      "adjuvant chemotherapy", 
      "overall survival", 
      "gastric cancer", 
      "retrospective multicenter cohort study", 
      "pilot study", 
      "pT1N1 gastric cancer", 
      "primary end point", 
      "multicenter cohort study", 
      "lympho-vascular invasion", 
      "high-volume hospitals", 
      "metastatic lymph nodes", 
      "high-risk group", 
      "depth of invasion", 
      "size of tumor", 
      "gastric cancer recurrence", 
      "location of tumor", 
      "prediction of benefit", 
      "core of tumor", 
      "cohort study", 
      "survival benefit", 
      "lymph nodes", 
      "retrospective study", 
      "gross type", 
      "risk groups", 
      "cancer recurrence", 
      "independent statistician", 
      "Lauren classification", 
      "end point", 
      "chemotherapy", 
      "Assay Kit", 
      "tumors", 
      "RNA expression", 
      "patients", 
      "surgery", 
      "predictive groups", 
      "cancer", 
      "death", 
      "survival", 
      "group", 
      "invasion", 
      "sample size", 
      "selection criteria", 
      "pT1N1", 
      "statistical analysis", 
      "recurrence", 
      "hospital", 
      "histology", 
      "study", 
      "trials", 
      "Eppendorf tubes", 
      "age", 
      "sex", 
      "tissue", 
      "cause", 
      "benefits", 
      "FFPE", 
      "kit", 
      "expression", 
      "RNA", 
      "criteria", 
      "classification", 
      "time", 
      "hypothesis", 
      "information", 
      "patterns", 
      "samples", 
      "laboratory", 
      "institutions", 
      "number", 
      "types", 
      "size", 
      "tube", 
      "nodes", 
      "analysis", 
      "results", 
      "block", 
      "location", 
      "reference", 
      "point", 
      "statisticians", 
      "same issue", 
      "issues", 
      "prediction", 
      "sample blocks", 
      "depth", 
      "core"
    ], 
    "name": "Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer: A Pilot Retrospective Multicenter Cohort Study", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT03485105"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2022-09-02T16:19", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20220902/entities/gbq_results/clinical_trial/clinical_trial_1.jsonl", 
    "startDate": "2017-11", 
    "subjectOf": [
      {
        "id": "sg:pub.10.1186/s12885-017-3265-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1084954648", 
          "https://doi.org/10.1186/s12885-017-3265-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10120-011-0041-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1016436945", 
          "https://doi.org/10.1007/s10120-011-0041-5"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT03485105"
  }
]
 

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.NCT03485105'

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

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT03485105'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT03485105'

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

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT03485105'


 

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

116 TRIPLES      15 PREDICATES      105 URIs      97 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT03485105 schema:about anzsrc-for:11
2 anzsrc-for:1112
3 schema:description To conduct a retrospective study to prove a hypothesis of "adjuvant chemotherapy provides survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in high-risk group". This study is a pilot study and the result will be used as a reference for the upcoming prospective randomized controlled trial for same issue including estimating sample size. Two high-volume hospitals (Yonsei University Severance Hospital and Samsung Hospital) will participant this pilot study.FFPE sample blocks and clinical information pertaining to the patients who satisfied with selection criteria will be collected from two institutions. The primary end point of this study is disease-free survival (DFS) that is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined as time from surgery to death by any causes. Clinical information such as age, sex, histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received chemotherapy or not will be centralized.One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from the tissue and the pattern of RNA expression will be evaluated and each sample will be categorized into three risk group (high, intermediate, low risk group) and two predictive group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be delivered to independent statisticians who are responsible to conduct statistical analyses.
4 schema:endDate 2019-11
5 schema:keywords Assay Kit
6 Eppendorf tubes
7 FFPE
8 Lauren classification
9 RNA
10 RNA expression
11 adjuvant chemotherapy
12 age
13 analysis
14 benefits
15 block
16 cancer
17 cancer recurrence
18 cause
19 chemotherapy
20 classification
21 clinical information
22 cohort study
23 core
24 core of tumor
25 criteria
26 death
27 depth
28 depth of invasion
29 disease-free survival
30 end point
31 expression
32 gastric cancer
33 gastric cancer recurrence
34 gross type
35 group
36 high-risk group
37 high-volume hospitals
38 histology
39 hospital
40 hypothesis
41 independent statistician
42 information
43 institutions
44 invasion
45 issues
46 kit
47 laboratory
48 location
49 location of tumor
50 lymph nodes
51 lympho-vascular invasion
52 metastatic lymph nodes
53 multicenter cohort study
54 nodes
55 number
56 overall survival
57 pT1N1
58 pT1N1 gastric cancer
59 patients
60 patterns
61 pilot study
62 point
63 prediction
64 prediction of benefit
65 predictive groups
66 primary end point
67 recurrence
68 reference
69 results
70 retrospective multicenter cohort study
71 retrospective study
72 risk groups
73 same issue
74 sample blocks
75 sample size
76 samples
77 selection criteria
78 sex
79 size
80 size of tumor
81 statistical analysis
82 statisticians
83 study
84 surgery
85 survival
86 survival benefit
87 time
88 tissue
89 trials
90 tube
91 tumors
92 types
93 schema:name Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer: A Pilot Retrospective Multicenter Cohort Study
94 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT03485105
95 schema:sdDatePublished 2022-09-02T16:19
96 schema:sdLicense https://scigraph.springernature.com/explorer/license/
97 schema:sdPublisher Nf0038fd70abc4ed99e8fa6eb74cd633c
98 schema:startDate 2017-11
99 schema:subjectOf sg:pub.10.1007/s10120-011-0041-5
100 sg:pub.10.1186/s12885-017-3265-x
101 schema:url https://clinicaltrials.gov/show/NCT03485105
102 sgo:license sg:explorer/license/
103 sgo:sdDataset clinical_trials
104 rdf:type schema:MedicalStudy
105 Nf0038fd70abc4ed99e8fa6eb74cd633c schema:name Springer Nature - SN SciGraph project
106 rdf:type schema:Organization
107 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
108 rdf:type schema:DefinedTerm
109 anzsrc-for:1112 schema:inDefinedTermSet anzsrc-for:
110 rdf:type schema:DefinedTerm
111 sg:pub.10.1007/s10120-011-0041-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1016436945
112 https://doi.org/10.1007/s10120-011-0041-5
113 rdf:type schema:CreativeWork
114 sg:pub.10.1186/s12885-017-3265-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1084954648
115 https://doi.org/10.1186/s12885-017-3265-x
116 rdf:type schema:CreativeWork
 




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


...