Colonography Versus Colonoscopy in High Risk Patient

NCT00748449 | Terminated

• 1 other identifier: P051074
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colorectal advanced adenoma; Colorectal cancer polypectomy (endoscopic); Colectomy; Colonoscopy with anaesthesia; CT-colonography

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who refuse to undergo an examination

  36 months

Study Arms (2)

1

ACTIVE COMPARATOR

CT Colonography

Procedure: CT-colonography

2

ACTIVE COMPARATOR

Colonoscopy

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

1 Colonoscopy

Also known as: Colonoscopy or CT-colonography

2

CT-colonography PROCEDURE

1 CT-colonography; Procedure/Surgery/Radiation

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Frederic PRAT, MD, PhD

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: September 8, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (1)