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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Procedure: Colonoscopy; Procedure: CT-colonography	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
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 Start Date :	June 2008
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	December 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Colonoscopy or CT-colonography

Outcome Measures

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Primary Outcome Measures :

1. Percentage of patients who refuse to undergo an examination [ Time Frame: 36 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Cochin
Paris, France, 75014

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Frederic PRAT, MD, PhD	Assistance Publique - Hôpitaux de Paris

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00748449 History of Changes
Other Study ID Numbers:	P051074
First Posted:	September 8, 2008
Last Update Posted:	September 12, 2011
Last Verified:	August 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Colorectal advanced adenoma; Colorectal cancer polypectomy (endoscopic); Colectomy; Colonoscopy with anaesthesia; CT-colonography

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms	Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases