Ireland
--:--IST
Recruiting Not applicable

Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers

NCT04103567 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-01-14
Last updated
2025-02-12

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Biological collection

Biological collection: Fecal samples collected at different times : during inclusion consultation with surgeon, after neoadjuvant treatment and before surgery.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The ratio between the proportions of poor response to neoadjuvant treatment in populations so-called "exposed" (patients colonized by bacteria producing toxins (cyclomodulin) and unexposed (patients not colonized by bacteria producing toxins) — About 1 years

Trial sites (2)

FacilityCityRegionStatus
Institut régional du Cancer de Montpellier Montpellier Hérault Recruiting
CHU Clermont-Ferrand Clermont-Ferrand Puy De Dôme Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04103567 on ClinicalTrials.gov ↗ ← All trials in France