Colonography Versus Colonoscopy in High Risk Patient

Not Applicable

Terminated

• Conditions: Colorectal Cancer
• Interventions: Procedure: CT-colonography; Procedure: Colonoscopy

• Registration Number: NCT00748449
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-08
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-09-09
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CT-colonography	CT Colonography
2	Colonoscopy	Colonoscopy

Primary Outcome Measures

Name	Time	Method
Percentage of patients who refuse to undergo an examination	36 months

Trial Locations

Locations (1)

Cochin; 🇫🇷 Paris, France