Skip to content

Colonography Versus Colonoscopy in High Risk Patient

Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00748449
Acronym
COLO-TDM
Enrollment
39
Registered
2008-09-08
Start date
2008-06-01
Completion date
2010-12-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

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

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

Interventions

PROCEDUREColonoscopy

1 Colonoscopy

1 CT-colonography; Procedure/Surgery/Radiation

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Percentage of patients who refuse to undergo an examination36 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFrederic PRAT, MD, PhD

Assistance Publique Hopitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026