Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-03-28

AUTHORS

Daniele Regge, Gabriella Iussich, Carlo Senore, Loredana Correale, Cesare Hassan, Alberto Bert, Stefania Montemezzi, Nereo Segnan

ABSTRACT

BackgroundColorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening.Methods/DesignAn invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests. Secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected.DiscussionThis study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting.Trial registrationClinicalTrials.gov Identifier: NCT01739608 More... »

PAGES

97

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1745-6215-15-97

DOI

http://dx.doi.org/10.1186/1745-6215-15-97

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1005648612

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24678896


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32 schema:description BackgroundColorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening.Methods/DesignAn invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests. Secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected.DiscussionThis study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting.Trial registrationClinicalTrials.gov Identifier: NCT01739608
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40 CRC
41 CRC cases
42 CRC screening tests
43 CT colonography
44 CTC arm
45 CTC testing
46 CTCs
47 DiscussionThis study
48 Europe
49 FS arm
50 Italy
51 Piedmont region
52 Secondary outcomes
53 Verona district
54 accurate examination
55 adenomas
56 adoption
57 advanced neoplasia detection
58 age
59 alternative screening test
60 analysis
61 arm
62 assessment
63 benefits
64 blood tests
65 bowel disease
66 burden
67 cancer
68 cases
69 colon
70 colonography
71 colonoscopy
72 colorectal cancer
73 comparison
74 computer-aided detection
75 control group
76 cost
77 cost-effectiveness analysis
78 data
79 detection
80 detection rate
81 differences
82 disease
83 distal colon
84 district
85 eligible subjects
86 entire colon
87 examination
88 fecal occult blood test
89 first-degree relatives
90 flexible sigmoidoscopy
91 general practitioners
92 group
93 history
94 history of CRC
95 identifiers
96 individuals
97 inflammatory bowel disease
98 information
99 intervention
100 intervention group
101 invitation
102 invitation letter
103 letter
104 mass screening intervention
105 mortality
106 multicenter
107 neoplasia detection
108 occult blood test
109 one-third
110 outcome parameters
111 outcomes
112 parameters
113 part
114 participation
115 participation rates
116 people
117 population
118 population-based screening
119 practitioners
120 prevalent type
121 prevents
122 primary outcome parameter
123 primary test
124 procedure
125 protocol
126 proximal CRC
127 rate
128 reasons
129 recent colonoscopy
130 referral rates
131 region
132 relatives
133 reliable information
134 risk
135 role
136 samples
137 screen
138 screening
139 screening interventions
140 screening procedure
141 screening setting
142 screening test
143 setting
144 sigmoidoscopy
145 single flexible sigmoidoscopy
146 study
147 study protocol
148 subjects
149 test
150 testing
151 tomography colonography
152 trials
153 types
154 years
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