Emergence Of Bacterial Resistance To Antibiotics In The Digestive Microbiota Of Patients Treated With Anticancer Drugs

Study Overview

Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs

Solid cancers are frequently treated with chemotherapies that target the DNA of cancer cells. It has recently come to light that bacteria are also the target of chemotherapies used in oncology. The results of current studies demonstrate the close link between the composition of the microbiota, the immune system, toxicity and the efficacy or otherwise of anti-cancer treatments. In this context, the study will measure the influence of treatment with anticancer molecules known to activate the bacterial SOS response on the emergence of antibiotic-resistant commensal bacteria in the gut microbiota of cancer patients. Furthermore, this study will investigate the existence of a close link between changes in the intestinal microbiota determined by the induction or non-induction of the SOS response, bacterial translocation, the integrity of the intestinal barrier and the antitumor immune response. The RAMA trial plans to collect stool and blood samples from two different cohorts of patients: * Unexposed cohort: patients receiving anti-cancer treatment that does not induce bacterial SOS response. * Exposed cohort: patients receiving anti-cancer treatment inducing the bacterial SOS response. Patients' stools will be collected within 7 days of their first chemotherapy treatment and within 7 days of the 3rd chemotherapy cycle. Two blood samples will be taken at the same time as the stool samples. The results obtained from this prospective clinical research will then be investigated in two experimental laboratory models. The aim is to demonstrate that cytotoxic anticancer drugs promote the emergence of antibiotic-resistant commensal bacteria, by means of this large-scale study comprising a clinical component, which is the subject of the research presented in this protocol, combined with laboratory research components.

N/A

Cervical Cancers
Endometrial Cancer
Gynecological Cancers
Pancreatic Adenocarcinoma
Upper Aerodigestive Tract Carcinoma

OTHER: Mandatory biological samples (blood and sell)

2025-A00013-46

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-22
First Submitted that Met QC Criteria 2025-07-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-30
First Posted (ACTUAL) 2025-07-30	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: All cohorts For each cohort : * Collect of stool samples (cycle 1 and cycle 3) * Collect of blood samples (5 x 6 mL EDTA tubes) => Cycle 1 and Cycle 3	OTHER: Mandatory biological samples (blood and sell) At cycle 1 and Cycle 3 : * Stool sample collection * Blood sample collection (5 EDTA tubes)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: All cohorts

For each cohort : * Collect of stool samples (cycle 1 and cycle 3) * Collect of blood samples (5 x 6 mL EDTA tubes) => Cycle 1 and Cycle 3

OTHER: Mandatory biological samples (blood and sell)

At cycle 1 and Cycle 3 : * Stool sample collection * Blood sample collection (5 EDTA tubes)

Primary Outcome Measures	Measure Description	Time Frame
Determine whether the digestive microbiota of patients exposed to SOS-inducing cytotoxic cancer drugs favors the emergence of antibiotic-resistant commensal bacteria compared to patients exposed to other non-SOS-inducing cytotoxic cancer drugs.	The primary endpoint is the emergence of antibiotic-resistant Enterobacteriaceae, defined as the presence of Enterobacteriaceae resistant to 3rd-generation cephalosporins and/or fluoroquinolones on the sample taken within 7 days of administration of the 3rd cycle of chemotherapy, compared with the pretreatment initiation sample taken within 7 days of administration of the first cycle of chemotherapy.	up to 3 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sylvain LADOIRE, Professor

Phone Number: 03 80 73 75 00

Email: SLadoire@cgfl.fr

Study Contact Backup

Name: Anne-Laure REROLE, Projet manager

Phone Number: 03 45 34 88 46

Email: arerole@cgfl.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Men and women over 18
Chemotherapy-naive patients.
Patients due to start chemotherapy/radio chemotherapy who meet the criteria of the cohorts listed below :

OMS ≤ 2
Affiliation with a French social security scheme or beneficiary of such a scheme.
Signed informed consent indicating that the patient has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the study requirements and restrictions

Patients unable to collect / send stools for medical, geographical, social or psychological reasons.
Patients who have already received chemotherapy/radiochemotherapy.
Use of anti-infectives for systemic use within 6 months prior to the first sampling, or any other concomitant disease/condition that may influence stool analysis.
Pregnant women and nursing mothers.
Persons deprived of their liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social institution for purposes other than research.
Adults subject to a legal protection measure - safeguard of justice, guardianship or curatorship - or unable to express their consent.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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