Colonography Versus Colonoscopy in High Risk Patient (COLO-TDM)
Primary Purpose
Colorectal Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colonoscopy
CT-colonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colorectal advanced adenoma, Colorectal cancer polypectomy (endoscopic), Colectomy, Colonoscopy with anaesthesia, 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
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
Sites / Locations
- Cochin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
CT Colonography
Colonoscopy
Outcomes
Primary Outcome Measures
Percentage of patients who refuse to undergo an examination
Secondary Outcome Measures
Full Information
NCT ID
NCT00748449
First Posted
July 31, 2008
Last Updated
September 9, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00748449
Brief Title
Colonography Versus Colonoscopy in High Risk Patient
Acronym
COLO-TDM
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
No more inclusions
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal advanced adenoma, Colorectal cancer polypectomy (endoscopic), Colectomy, Colonoscopy with anaesthesia, CT-colonography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
CT Colonography
Arm Title
2
Arm Type
Active Comparator
Arm Description
Colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Other Intervention Name(s)
Colonoscopy or CT-colonography
Intervention Description
1 Colonoscopy
Intervention Type
Procedure
Intervention Name(s)
CT-colonography
Intervention Description
1 CT-colonography; Procedure/Surgery/Radiation
Primary Outcome Measure Information:
Title
Percentage of patients who refuse to undergo an examination
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic PRAT, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
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Colonography Versus Colonoscopy in High Risk Patient
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