Clinical trial · Observational
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".
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients Aged 50-75 and Requiring Colonoscopy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
- timeFrame
- up to 4 years
Secondary outcomes (2)
- measure
- 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
- timeFrame
- up to 4 years
- measure
- 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.
- timeFrame
- up to 20 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available