Colonography Versus Colonoscopy in High Risk Patient (COLO-TDM)
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| ClinicalTrials.gov Identifier: NCT00748449 |
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Recruitment Status :
Terminated
(No more inclusions)
First Posted : September 8, 2008
Last Update Posted : September 12, 2011
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Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Procedure: Colonoscopy Procedure: CT-colonography | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 39 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2010 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
CT Colonography
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Procedure: CT-colonography
1 CT-colonography; Procedure/Surgery/Radiation |
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Active Comparator: 2
Colonoscopy
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Procedure: Colonoscopy
1 Colonoscopy
Other Name: Colonoscopy or CT-colonography |
Primary Outcome Measures :
- Percentage of patients who refuse to undergo an examination [ Time Frame: 36 months ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00748449 History of Changes |
| Other Study ID Numbers: |
P051074 |
| First Posted: | September 8, 2008 Key Record Dates |
| Last Update Posted: | September 12, 2011 |
| Last Verified: | August 2011 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
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Colorectal advanced adenoma Colorectal cancer polypectomy (endoscopic) Colectomy Colonoscopy with anaesthesia CT-colonography |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |