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

Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer

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

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: CT-colonography; Procedure: Colonoscopy

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; CT Colonography	Procedure: CT-colonography; 1 CT-colonography; Procedure/Surgery/Radiation
Active Comparator: 2; Colonoscopy	Procedure: Colonoscopy; 1 Colonoscopy; Other Names: Colonoscopy or CT-colonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who refuse to undergo an examination	36 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Frederic Prat, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 31, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (Estimate): September 8, 2008

Study Record Updates

• Last Update Posted (Estimate): September 12, 2011
• Last Update Submitted That Met QC Criteria: September 9, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Colectomy; Colorectal advanced adenoma; Colorectal cancer polypectomy (endoscopic); Colonoscopy with anaesthesia; CT-colonography
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: P051074