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

This study has been terminated.

(No more inclusions)

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00748449

First received: July 31, 2008

Last updated: September 9, 2011

Last verified: August 2011

History of Changes

Purpose

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

Condition	Intervention
Colorectal Cancer	Procedure: Colonoscopy Procedure: CT-colonography


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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


Enrollment:	39
Study Start Date:	June 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748449

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


Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00748449 History of Changes
Other Study ID Numbers:	P051074
Study First Received:	July 31, 2008
Last Updated:	September 9, 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

ClinicalTrials.gov processed this record on July 21, 2017

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