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Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers
RECRUITINGN/ASponsored by Institut du Cancer de Montpellier - Val d'Aurelle
Actively Recruiting
PhaseN/A
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Started2020-01-14
Est. completion2026-01-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04103567
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
CancerRectal Cancer
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Actively Recruiting
PhaseN/A
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Started2020-01-14
Est. completion2026-01-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04103567