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NCT Number: NCT07093593

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.

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Key information

Conditions

Cervical Cancers Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gynecological Cancers Neoplasms Neoplasms by Site Pancreatic Adenocarcinoma Upper Aerodigestive Tract Carcinoma Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Squamous cell carcinoma of the upper aerodigestive tract (Non-metastatic, locally advanced, operable or not; Patients receiving concomitant radiochemotherapy using a platinum salt (cisplatin, carboplatin))
Cervical and endometrial cancer (ocally advanced, Non-metastatic; Patients receiving concomitant radiochemotherapy using a platinum salt (cisplatin, carboplatin))
Gynecological cancer (advanced stage ; Patient to receive platinum salt + paclitaxel chemotherapy)
Mammary carcinoma (localised; Patient to receive adjuvant or neoadjuvant chemotherapy with epirubicin and cyclophosphamide without other associated treatment (targeted therapy / immunotherapy))
Urothelial carcinoma (all stage ; Patient to receive neoadjuvant or adjuvant chemotherapy with platinum salt and gemcitabine)
Pancreatic adenocarcinoma (localised or metastatic ; Patients to be treated with gemcitamine alone or in combination with nab-paclitaxel)
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

Exclusion criteria

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.

Treatment and study plan

Mandatory biological samples (blood and sell)

Other

At cycle 1 and Cycle 3 :

Stool sample collection
Blood sample collection (5 EDTA tubes)

Primary outcomes

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.

Time frame: up to 3 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Laure REROLE, Projet manager

CONTACT

[email protected]

03 45 34 88 46 ext. +33

Sylvain LADOIRE, Professor

CONTACT

[email protected]

03 80 73 75 00 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs (Clinical Component of the RAMA Project)

Acronym: RAMA

Important dates

Study start: 2025
Primary completion: 2032
Study completion: 2032
First posted: Jul 30, 2025
Registry last updated: Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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