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

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ClinicalTrials.gov Identifier: NCT04103567
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief 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 radiochemotherapy in rectal cancer. This could lead to a better understanding and selection of patients for personalized treatment in rectal cancer.

Condition or disease Intervention/treatment Phase
Rectal Cancer Other: Biological collection Not Applicable

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 radiochemotherapy 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 radiochemotherapy in rectal cancer. This could lead to a better understanding and selection of patients for tailored treatment in rectal cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Therapy in Rectal Cancers: Focus on Cyclomodulin-producing Escherichia Coli
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : November 2027

Arm Intervention/treatment
Experimental: Biological collection

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




Primary Outcome Measures :
  1. The ratio between the proportions of poor response to neoadjuvant radiochemotherapy in populations so-called "exposed" (patients colonized by bacteria producing toxins (cyclomodulin) and unexposed (patients not colonized by bacteria producing toxins [ Time Frame: About 3 years ]

Secondary Outcome Measures :
  1. Change of cyclomodulin-Producing Escherichia Coli colonization rate before and after neoadjuvant radiotherapy [ Time Frame: About 3 years ]
  2. Change of cyclomodulin-Producing Escherichia Coli prevalence before and after neoadjuvant radiotherapy [ Time Frame: About 3 years ]
  3. Change of prevalence forming the overall bacterial composition before and after neoadjuvant radiochemotherapy [ Time Frame: About 3 years ]
  4. Change of colonization rate (in addition to cyclomodulin-Producing Escherichia Coli) forming the overall bacterial composition before and after neoadjuvant radiochemotherapy [ Time Frame: About 3 years ]
  5. Relative risk of poor response to neoadjuvant radiochemotherapy in colonized patients with other bacteria ("exposed") compared to non-colonized patients ("unexposed") [ Time Frame: About 8 years ]
  6. Proportion of patients colonized according to the modality of the clinical variable age [ Time Frame: About 3 years ]
  7. Proportion of patients colonized according to the modality of the clinical variable gender [ Time Frame: About 3 years ]
  8. Proportion of patients colonized according to the modality of the clinical variable body mass index [ Time Frame: About 3 years ]
  9. 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 8 years ]
  10. 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 8 years ]
  11. 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 8 years ]
  12. Types of other bacteria forming the overall bacterial composition before neoadjuvant radiochemotherapy [ Time Frame: About 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III
  2. Patient is to receive neoadjuvant treatment by radiochemotherapy (capecitabine 825 mg/m² twice a day + radiotherapy 50 gy) according to French recommendations
  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 chemotherapy 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103567


Contacts
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Contact: Jean-Pierre Bleuse, MD 4 67 61 31 02 ext +33 jean-pierre.bleuse@icm.unicancer.fr

Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Chair: Guillaume Carrier, MD Institut régional du cancer de Montpellier

Publications:

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT04103567    
Other Study ID Numbers: PROICM 2019-14-MIR
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
rectal
cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases