NCT04103567 Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers
| NCT ID | NCT04103567 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2020-01-14 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2020-01-14 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this project is to determine in a non-invasive manner (fecal samples) the predictive value of the intestinal microbiota and the presence of genotoxin-producing bacteria on the response to neoadjuvant treatment in rectal cancer. This could lead to a better understanding and selection of patients for personalized treatment in rectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III 2. Patient is to receive neoadjuvant treatment (radiochemotherapy or chemotherapy or radiotherapy). Induction chemotherapy such as folfox or folfirinox is allowed 3. Patient who has signed the informed consent of the study 4. Male or female ≥ 18 years old 5. Appropriate contraceptive measures should be used by both men and non-menopausal women before entering the trial until at least 8 weeks after the last course of radiochemotherapy. The investigator should inform the patient about the contraceptive measures to be used. Exclusion Criteria: 1. Antibiotic treatment at the time or in the month preceding stool sampling 2. Presence of an ostomy 3. Previous treatment for rectal cancer 4. Patient not affiliated to a French social protection system 5. Patient not in favour of good compliance with treatment for psychological, family, social or geographical reasons 6. Legal incapacity (Patient under curatorship or guardianship) 7. Prior radiation therapy or pelvic curia in the year prior to inclusion 8. History of other cancers in the last 5 years (except for in-situ cervical carcinomas and non-melanoma skin carcinomas treated optimally) 9. Pregnant or breastfeeding woman
Contact & Investigator
Philippe ROUANET, MD
STUDY CHAIR
Institut régional du cancer de Montpellier
Frequently Asked Questions
Who can join the NCT04103567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04103567 currently recruiting?
Yes, NCT04103567 is actively recruiting participants. Contact the research team at Aurore.Moussion@icm.unicancer.fr for enrollment information.
Where is the NCT04103567 trial being conducted?
This trial is being conducted at Montpellier, France, Clermont-Ferrand, France.
Who is sponsoring the NCT04103567 clinical trial?
NCT04103567 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. The principal investigator is Philippe ROUANET, MD at Institut régional du cancer de Montpellier. The trial plans to enroll 220 participants.
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