Patients Aged 50-75 and Requiring ColonoscopyNCT06174233
The French Gut-colo
An observational study of Patients Aged 50-75 and Requiring Colonoscopy, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients Aged 50-75 and Requiring Colonoscopy
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2024to 17 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients aged between 50 and 75 scheduled for colonoscopy as part of routine care.
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Avicenne, Centre de Recherche sur Volontaire
Bobigny, 93000
Robert BENAMOUZIG, Pr, robert.benamouzig@aphp.fr
Mourad BENALLAOUA, mourad.benallaoua@aphp.fr
About this study
Official title: "Contribution of Metagenomic Analysis of Faecal Microbiota Combined With Artificial Intelligence for the Prediction of Colorectal Cancer Risk; Study in Patients Scheduled for Colonoscopy".
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.
Read the detailed description
Many CRC risk factors, such as obesity, low physical activity, a diet low in fibre and high in fat and red meat, and chronic inflammation of the gastrointestinal tract, are known to interact with the intestinal microbiota. Recent studies have identified microbiota signatures associated with colon cancer. These CRC signatures could be used as a solid basis for future screening tests.
This study is an ancillary study of "Le French Gut" study (NCT05758961), a national contribution aiming to collect 100,000 faecal samples and associated nutritional and clinical data. Here, the aim is to identify microbiota profiles associated with the presence of adenomas, advanced adenomas and colorectal cancer (CRC), which would make it possible to recommend follow-up colonoscopies in a more targeted way than the current screening method. The study involves 2,500 patients aged between 50 and 75 who were due to undergo colonoscopy as part of their routine care. Patients recruited in this way will take part in the main "Le French Gut" study, will undergo a colonoscopy as part of their routine care and will complete 2 specific questionnaires relating to their personal and family history as well as their dietary habits in order to assess the risk factors for colorectal cancer as accurately as possible. The FIT test will be carried out as part of routine care with home sampling at the same time as stool sampling using the stool collection kit from the "French Gut" study (same stool sample).
Metagenomic fecal analysis will be coupled with a federated artificial intelligence tool incorporating data collected as part of the French Gut study and specific parameters describing the level of CRC risk. The diagnostic value of the signatures will be compared with that of the FIT test currently used for CRC screening.The ultimate aim is to develop more accurate, non-invasive ways of predicting CRC risk, based on a non-invasive fecal swab that can be taken at home.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 years
Secondary outcomes (2)
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
Measured: up to 4 years
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.
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start17 Jun 2024
- Primary completion17 Jun 2029 (estimated)
- Study completion17 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Aged 50-75 and Requiring ColonoscopyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- ROBERT BENAMOUZIG, Pr, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174233
- Sponsor's protocol ID
- 2023-A01941-44
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Contribution of Metagenomic Analysis of Faecal Microbiota Combined With Artificial Intelligence for the Prediction of Colorectal Cancer Risk; Study in Patients Scheduled for Colonoscopy".
- ClinicalTrials.gov ID
- NCT06174233
- Acronym / sponsor ID
- 2023-A01941-44
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 17 Jun 2029 (estimated)
- Study completion
- 17 Dec 2029 (estimated)
- First posted
- 18 Dec 2023 (actual)
- 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.
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.
Detailed description
Many CRC risk factors, such as obesity, low physical activity, a diet low in fibre and high in fat and red meat, and chronic inflammation of the gastrointestinal tract, are known to interact with the intestinal microbiota. Recent studies have identified microbiota signatures associated with colon cancer. These CRC signatures could be used as a solid basis for future screening tests.
This study is an ancillary study of "Le French Gut" study (NCT05758961), a national contribution aiming to collect 100,000 faecal samples and associated nutritional and clinical data. Here, the aim is to identify microbiota profiles associated with the presence of adenomas, advanced adenomas and colorectal cancer (CRC), which would make it possible to recommend follow-up colonoscopies in a more targeted way than the current screening method. The study involves 2,500 patients aged between 50 and 75 who were due to undergo colonoscopy as part of their routine care. Patients recruited in this way will take part in the main "Le French Gut" study, will undergo a colonoscopy as part of their routine care and will complete 2 specific questionnaires relating to their personal and family history as well as their dietary habits in order to assess the risk factors for colorectal cancer as accurately as possible. The FIT test will be carried out as part of routine care with home sampling at the same time as stool sampling using the stool collection kit from the "French Gut" study (same stool sample).
Metagenomic fecal analysis will be coupled with a federated artificial intelligence tool incorporating data collected as part of the French Gut study and specific parameters describing the level of CRC risk. The diagnostic value of the signatures will be compared with that of the FIT test currently used for CRC screening.The ultimate aim is to develop more accurate, non-invasive ways of predicting CRC risk, based on a non-invasive fecal swab that can be taken at home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged between 50 and 75 scheduled for colonoscopy as part of routine care.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 years
2 secondary outcomes
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 years
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 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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.
ROBERT BENAMOUZIG, Pr principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Aged 50-75 and Requiring Colonoscopy, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ROBERT BENAMOUZIG, Pr (00148955434, robert.benamouzig@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 4 years). 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 29 Oct 2026.