Cervical CancersRAMANCT07093593
Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs
A study testing Mandatory biological samples (blood and sell) in people with Cervical Cancers and Endometrial Cancer, run by Centre Georges Francois Leclerc.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancers, Endometrial Cancer, Gynecological Cancers
- What is being tested?
- Mandatory biological samples (blood and sell)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs (Clinical Component of the RAMA Project)
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.
Read more
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.
- Conditions
- Cervical Cancers, Endometrial Cancer, Gynecological Cancers, Pancreatic Adenocarcinoma, Upper Aerodigestive Tract Carcinoma
- Being tested
- Mandatory biological samples (blood and sell)
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandatory biological samples (blood and sell)Other
At cycle 1 and Cycle 3 :
- Stool sample collection
- Blood sample collection (5 EDTA tubes)
| Study group | Role | What they receive |
|---|---|---|
| All cohorts | Experimental | 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 Receives: Other: Mandatory biological samples (blood and sell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2032 (estimated)
- Study completion1 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093593
- Sponsor's protocol ID
- 2025-A00013-46
- Acronym
- RAMA
- Status last verified
- Jul 2025
- First submitted
- 2 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs (Clinical Component of the RAMA Project)
- ClinicalTrials.gov ID
- NCT07093593
- Acronym / sponsor ID
- RAMA / 2025-A00013-46
- Conditions
- Cervical Cancers, Endometrial Cancer, Gynecological Cancers, Pancreatic Adenocarcinoma, Upper Aerodigestive Tract Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2032 (estimated)
- Study completion
- 1 Sep 2032 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All cohorts | Experimental | Other: Mandatory biological samples (blood and sell)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandatory biological samples (blood and sell)At cycle 1 and Cycle 3 : * Stool sample collection * Blood sample collection (5 EDTA tubes) | Other | All cohorts |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mandatory biological samples (blood and sell) in people with Cervical Cancers and Endometrial Cancer, run by Centre Georges Francois Leclerc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain LADOIRE, Professor (03 80 73 75 00 ext. +33, SLadoire@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.