Colorectal CancerCOLO-TDMNCT00748449
Colonography Versus Colonoscopy in High Risk Patient
A study testing Colonoscopy and CT-colonography in people with Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of advanced adenomas in subpopulations at high risk of colorectal. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopy and CT-colonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer
to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of advanced adenomas in subpopulations at high risk of colorectal.
Read the 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
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopy, CT-colonography
- Keywords
- Colorectal advanced adenoma, Colorectal cancer polypectomy (endoscopic), Colectomy, Colonoscopy with anaesthesia, CT-colonography
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Also called Colonoscopy or CT-colonography
1 Colonoscopy
CT-colonographyProcedure or surgery
1 CT-colonography; Procedure/Surgery/Radiation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CT Colonography Receives: Procedure: CT-colonography |
| 2 | Active comparator | Colonoscopy Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who refuse to undergo an examination
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionDec 2010
Why it stopped: No more inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Frederic PRAT, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748449
- Sponsor's protocol ID
- P051074
- Acronym
- COLO-TDM
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2008
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00748449
- Acronym / sponsor ID
- COLO-TDM / P051074
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal advanced adenoma, Colorectal cancer polypectomy (endoscopic), Colectomy, Colonoscopy with anaesthesia, CT-colonography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more inclusions
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: CT-colonographyCT Colonography |
| 2 | Active comparator | Procedure: ColonoscopyColonoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyAlso: Colonoscopy or CT-colonography1 Colonoscopy | Procedure or surgery | 2 |
| CT-colonography1 CT-colonography; Procedure/Surgery/Radiation | Procedure or surgery | 1 |
Primary outcome
Percentage of patients who refuse to undergo an examination
Time frame: 36 months
Results and safety
The study was stopped early (reason given: No more inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Related trials for Colorectal Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
Active, not recruitingPhase 2/3
Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic PRAT, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy and CT-colonography in people with Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No more inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who refuse to undergo an examination (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.