Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Percentage of patients who refuse to undergo an examination
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
CT Colonography
Intervention: CT-colonography (Procedure)
2
Colonoscopy
Intervention: Colonoscopy (Procedure)
Outcomes
Primary Outcomes
Percentage of patients who refuse to undergo an examination
Time Frame: 36 months
Secondary Outcomes
No secondary outcomes reported