Colonography Versus Colonoscopy in High Risk Patient (COLO-TDM)

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Conditions

Colorectal Cancer

Treatments

Procedure: Colonoscopy

Procedure: CT-colonography

Study type

Interventional

Funder types

Other

Identifiers

NCT00748449

P051074

Details and patient eligibility

About

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

Full 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

Enrollment

39 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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