Colonography Versus Colonoscopy in High Risk Patient

Study Overview
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Brief Summary
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to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of advanced adenomas in subpopulations at high risk of colorectal.

Detailed Description
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Secondary objective: to evaluate the medical and economic impact of the implementation of CT- colonography in this setting.Methodology: prospective multicenter randomized controlled trial with direct patient benefitN° of patients to be included: 600 Study follow-up :1 consultation and 3 phone contacts (M1, M6 and M12)Evaluation criteria:Main endpoint: acceptability of the colorectal cancer screening (% of enrolled patients having actually undergone the exploration)Secondary endpoints: - cost/effectiveness ratio of the 2 diagnostic tests with calculation of the economic and medical costs. - number of advanced adenoma detected in each group- number of CRC cases detected in each group

Official Title
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Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Colonoscopy
* Procedure: CT-colonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surveillance of patients with a personal history of advanced adenoma or CRC: Informed consent obtained Age ≥ 18 and ≤ 80 years old History of advanced adenomatous polyps Or history of non metastatic CRC with curative surgery and without other treatment more than 2 years before enrollment. Previous medical examination Screening of patients with a Family history of CRC at high risk: Informed consent obtained Age ≥ 18 and ≤ 80 years old First degree family history of colorectal cancer diagnosed <60yrs during the five previous years-Previous medical examination Exclusion Criteria: Personal histories Age < 18 or >80 years old history of non adenomatous polyps history of Metastatic CRC familial adenomatous polyposis, Peutz-Jeghers syndrome, hereditary non polyposis colorectal cancer (HNPCC), juvenile polyposis syndrome Familial history of familial adenomatous polyposis Personal history of subtotal colectomy (but not of hemicolectomy, to confer to inclusion criteria) Colonoscopy with a polyps resection dated more than 5 years and less than 2 years prior to enrollment. Enrollment in another protocol no health insurance affiliation Family histories Age < 18 or >80 years old Patients with one or several family histories of first degree colorectal cancer occured to unknown age or diagnosed after 60 years old. Eligible patients having already undergone colonoscopy screening no health insurance affiliation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>CT Colonography | Procedure: CT-colonography<br>* 1 CT-colonography; Procedure/Surgery/Radiation<br>|
| Active Comparator: 2<br>Colonoscopy | Procedure: Colonoscopy<br>* 1 Colonoscopy<br>* Other names: Colonoscopy or CT-colonography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who refuse to undergo an examination |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal advanced adenoma, Colorectal cancer polypectomy (endoscopic), Colectomy, Colonoscopy with anaesthesia, CT-colonography