Clinical trial NCT00748449: Colonography Versus Colonoscopy in High Risk Patient
Official title: Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal advanced adenoma
Colorectal cancer polypectomy (endoscopic)
Colectomy
Colonoscopy with anaesthesia
CT-colonography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who refuse to undergo an examination
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frederic PRAT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: