- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01270360
Validation of an Alternative Biological Test to Increase the Detection Sensitivity of a Colon Tumour (VATNIMAD)
Validation of a Non Invasive methylateDNA Test for te Diagnosis of Colorectal Tumour in Asymptomatic Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study search to validate a test by taking advantage of the biotechnical expertise from renowned academic research teams and mass screening organisation.
In order to reduce the cost of the present study the investigators will select in this preliminary study only those individuals who have a FOBT. However, we'll measure the blood level by using a I-FOBT test to quantify Haemoglobin concentration in stools. Furthermore, we'll use stool DNA to characterize microbiota according to the colonoscopy findings. In addition, the investigators believe it is important to include in the project, the creation of biological blood and urine collections from individuals having undergone both faecal tests and a reference colonoscopy. In the future, these collections will be made available to the national or international scientific community (after consent by the principal investigators) to validate any other molecular and/or protein marker including proteomic analysis by using MSS. The investigators will perform methylated DNA test in either stools or blood and will compare results to those of I-FOBT and colonoscopy.
A simplified molecular test based on a combination of the search for methylation anomalies (one PCR and/or dedicated microarray) a limited number of gene targets involved in colorectal carcinogenesis is available. The investigators will collect stools, urine, and blood in a period of 15 to 2 days prior to colonoscopy. The colonoscopy is performed in 50-74 years old asymptomatic individuals who have presented with a positive FOBT test under mass screening organisation. A final point will be performed 5 years after entry in the trial for all 1000 individuals in order to check occurrence (alternative absence) of any disease during this period and the type of the disease for those individuals who will be shown with normal colonoscopy and to verify evolution of those who will presented with a colon or rectal tumor. Likelihood value of marker in diseases occurring during the survey period will be calculated and prognostic values estimated in those with colon or rectal cancer.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Creteil, France, 94010
- Henri Mondor Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Every person (actually limited to the average risk of colorectal cancer in national French program):
- having been invited to participate in the organised screening for a colorectal tumour during the study period and having a result positive of the FOBTt
- having given his consent to participate in the study. Patients will be given an information notice at the start of the campaign informing them that participation in this part of the study is optional, to prevent uselessly encumbering the screening campaign operation. Written consent will be obtained before the colonoscopy by the GE for this part of the study
- going to a laboratory to hand over samples of stools, urine and blood prior to the colonoscopy
- being affiliated to social security
Exclusion Criteria:
- Those refusing the colonoscopy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
asymptomatic subjects with positive FOBT
individuals having undergone a positive faecal occult blood test (FOBT) and a reference colonoscopy
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Detection of human colon or rectal tumours by using a simplified molecular test based on either a combination of methylated DNA or protein marker(s) alone or considered together in biological fluids like blood, urine and stools
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the performances (sensitivity, specificity and likelihood ratios) of a panel of blood and/or faecal molecular DNA markers
Time Frame: 3 years
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To determine the performances (sensitivity, specificity and likelihood ratios) of a panel of blood and/or faecal molecular DNA markers
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To estimate the cost and cost-effectiveness of adding DNA molecular tests to FOBT positive patients prior to colonoscopy
Time Frame: 3 years
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To estimate the cost and cost-effectiveness of adding DNA molecular tests to FOBT positive patients prior to colonoscopy
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3 years
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To determine the performances (sensitivity, specificity and likelihood ratios) of a panel of blood and/or faecal molecular protein markers
Time Frame: 3 years
|
To determine the performances (sensitivity, specificity and likelihood ratios) of a panel of blood and/or faecal molecular protein markers
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3 years
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To create biological collections for screening purposes (asymptomatic subjects)
Time Frame: 3 years
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To create biological collections for screening purposes (asymptomatic subjects)
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3 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Iradj Sobhani, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Sobhani I, Bergsten E, Charpy C, Chamaillard M, Mestivier D. Virulent Bacteria as Inflammatory and Immune Co-Factor in Colon Carcinogenesis: Evidence From Two Monozygotic Patients and Validation in CRC Patient and Healthy Cohorts. Front Cell Infect Microbiol. 2021 Nov 4;11:749750. doi: 10.3389/fcimb.2021.749750. eCollection 2021.
- Sobhani I, Bergsten E, Couffin S, Amiot A, Nebbad B, Barau C, de'Angelis N, Rabot S, Canoui-Poitrine F, Mestivier D, Pedron T, Khazaie K, Sansonetti PJ. Colorectal cancer-associated microbiota contributes to oncogenic epigenetic signatures. Proc Natl Acad Sci U S A. 2019 Nov 26;116(48):24285-24295. doi: 10.1073/pnas.1912129116. Epub 2019 Nov 11.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOM 09268
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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