The French Gut-colo
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-75
SponsorInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About this trial
Colorectal cancer (CRC) is the second most common type of cancer worldwide. The European Union recommends national CRC screening for people aged between 50 and 74. Generally, an immunological test called FIT (Fecal Immunochemical Test), based on the quantitative detection of human haemoglobin, is performed on a stool sample. If the haemoglobin level is above the recommended threshold, a colonoscopy is recommended to detect colorectal lesions. Recent studies have identified potential microbiota signatures associated with colon cancer. In this study, we will analyze the microbiota of a population aged 50 to 75 years undergoing colonoscopy as part of routine care in order to confirm the presence of microbiota signatures associated with the presence of adenomas, advanced adenomas and CRC.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between the ages of 50 and 75
Requiring colonoscopy
Able to provide a faecal sample and to perform a FIT test prior to colonoscopy
Without known inflammatory bowel disease (chronic inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC) and Crohn's disease (CD))
Disqualifiers
Persons not living in France (declaratory);
Persons subject to a protective measure, in particular guardianship or trusteeship, or unable to express their consent (declarative);
Persons who have had a colectomy (declaratory);
Person with a digestive stoma (declaration);
Trial population
patients aged between 50 and 75 scheduled for colonoscopy as part of routine care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Measurement of true-negative, true-positive, false-negative and false-positive rates after colonoscopy, associated with the new test based on metagenomic analysis and clinical data.
Time frame
up to 4 yearsSecondary outcomes
1
Define and compare the true-negative, true-positive false-negative and false-positive rates after colonoscopy associated with the new test compared with those of the FIT test
Time frame
up to 4 years2
Compare the rates of true negatives, false-negative true positives and false-positives after colonoscopy associated with the new test with those of the FIT test: number of cases aggregated at 5 years, 10 years, 15 years and 20 years.
Time frame
up to 20 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborator
Source ClinicalTrials.gov