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
  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:


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 ] [ Designated as safety issue: No ]

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
Other Name: CT-colonography
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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: France: Ministry of Health

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 September 18, 2014