The French Gut-colo
"Contribution of Metagenomic Analysis of Faecal Microbiota Combined With Artificial Intelligence for the Prediction of Colorectal Cancer Risk; Study in Patients Scheduled for Colonoscopy".
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
2,500 participants
Jun 26, 2024
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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))
- No medical condition that, in the opinion of the investigator, should preclude inclusion in the study
- Not having participated in any other clinical research study in which an investigational drug has been administered within 60 days prior to and including the date of informed consent or is likely to be administered during the period of colonoscopy
- Participation agreement signed electronically
Exclusion Criteria9
- 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);
- Person who did not sign the consent form;
- Person who did not answer the entry questionnaire;
- Person who did not send a compliant stool sample;
- Antibiotics taken in the 3 months prior to inclusion (self-report);
- Person aged under 50 or over 75.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06174233