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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 31, 2008
Last Updated
September 9, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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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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