Colonography Versus Colonoscopy in High Risk Patient

NCT ID: NCT00748449

Last Updated: 2011-09-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-12-31

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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

CT Colonography

Group Type: ACTIVE_COMPARATOR

CT-colonography

Intervention Type: PROCEDURE

1 CT-colonography; Procedure/Surgery/Radiation

2

Colonoscopy

Group Type: ACTIVE_COMPARATOR

Colonoscopy

Intervention Type: PROCEDURE

1 Colonoscopy

Interventions

Colonoscopy

1 Colonoscopy

Intervention Type: PROCEDURE

CT-colonography

1 CT-colonography; Procedure/Surgery/Radiation

Intervention Type: PROCEDURE

Other Intervention Names

Colonoscopy or CT-colonography

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

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic PRAT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Cochin

Paris, , France

Countries

France

Other Identifiers

P051074

Identifier Type: -

Identifier Source: org_study_id