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

This study has been terminated.
(No more inclusions)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: July 31, 2008
Last updated: September 9, 2011
Last verified: August 2011
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 ]

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
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

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

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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Please refer to this study by its identifier: NCT00748449

Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Frederic PRAT, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris 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)
Colonoscopy with anaesthesia

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 21, 2017