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

September 25, 2023 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Therapy in Rectal Cancers: Focus on Cyclomodulin-producing Escherichia Coli

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rectal cancer is the 8th leading cause of cancer in the world with more than 300,000 deaths in 2018. In addition to surgery, neoadjuvant treatment has proven its value in reducing local recurrences. Evaluation of the response to neoadjuvant treatment (essential for the subsequent therapeutic decision but also for the oncological prognosis. It is based on rectal magnetic resonance imaging, completed after surgery by anatomopathology. A personalised treatment with therapeutic de-escalation or intensification for aggressive tumours can be decided depending on the response to Neoadjuvant treatment. Thus, knowledge of the predictive factors of response to neoadjuvant treatment would permit to anticipate and adapt care.

The intestinal microbiota is a true microbial organ, playing a major role in maintaining intestinal homeostasis. Some bacterial species have been identified and suspected of playing a role in colorectal carcinogenesis. Among these species, genotoxin-producing Escherichia coli (CPEC) strains such as colibactin (cyclomodulin encoded by the genomic islet pks) are preferentially detected in patients with colorectal cancer (CRC), especially the most aggressive forms. Recent studies show that the intestinal microbiota is a prognostic factor in the response to certain chemotherapies or immunotherapies, but little work has been done on its potential influence on the effectiveness of radiotherapy. This suggests the possibility of using these biomarkers associated with response to neoadjuvant treatment.

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 tailored treatment in rectal cancer.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

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

Study Locations

  • France
    • Hérault
      • Montpellier, Hérault, France, 34298
    • Puy De Dôme

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological collection

Fecal samples collected at different times : During inclusion consultation with surgeon, after neoadjuvant treatment and before surgery,

In parallel to this fecal collection, standardized clinical data will be entered into a database
Other: Biological collection
Fecal samples collected at different times : during inclusion consultation with surgeon, after neoadjuvant treatment and before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: About 1 years
About 1 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of cyclomodulin-Producing Escherichia Coli colonization rate before and after neoadjuvant treatment
Time Frame: About 1 years
About 1 years
Change of cyclomodulin-Producing Escherichia Coli prevalence before and after neoadjuvant treatment
Time Frame: About 1 years
About 1 years
Change of prevalence forming the overall bacterial composition before and after neoadjuvant treatment
Time Frame: About 1 years
About 1 years
Change of colonization rate (in addition to cyclomodulin-Producing Escherichia Coli) forming the overall bacterial composition before and after neoadjuvant treatment
Time Frame: About 1 years
About 1 years
Relative risk of poor response to neoadjuvant treatment in colonized patients with other bacteria ("exposed") compared to non-colonized patients ("unexposed")
Time Frame: About 1 years
About 1 years
Proportion of patients colonized according to the modality of the clinical variable age
Time Frame: About 1 years
About 1 years
Proportion of patients colonized according to the modality of the clinical variable gender
Time Frame: About 1 years
About 1 years
Proportion of patients colonized according to the modality of the clinical variable body mass index
Time Frame: About 1 years
About 1 years
Overall survival in colonized people by the different types of bacteria that form the overall bacterial composition (including cyclomodulin-Producing Escherichia Coli) compared to non-colonized people
Time Frame: About 1 years
About 1 years
Disease-free survival in colonized people by the different types of bacteria that form the overall bacterial composition (including cyclomodulin-Producing Escherichia Coli) compared to non-colonized people
Time Frame: About 1 years
About 1 years
Specific survival in colonized people by the different types of bacteria that form the overall bacterial composition (including cyclomodulin-Producing Escherichia Coli) compared to non-colonized people
Time Frame: About 1 years
About 1 years
Types of other bacteria forming the overall bacterial composition before neoadjuvant treatment
Time Frame: About 1 years
About 1 years

Collaborators and Investigators

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Philippe Rouanet, MD, Institut Régional du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 14, 2020

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 30, 2030

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2019-14-MIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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