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

NCT04103567 | Recruiting

• 1 other identifier: PROICM 2019-14-MIR
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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

Conditions

Rectal Cancer

Keywords

rectal; cancer; cyclomodulin; microbiological factors

Outcome Measures

Primary Outcomes (1)

• 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)

  About 1 years

Secondary Outcomes (12)

• Change of cyclomodulin-Producing Escherichia Coli colonization rate before and after neoadjuvant treatment

  About 1 years

• Change of cyclomodulin-Producing Escherichia Coli prevalence before and after neoadjuvant treatment

  About 1 years

• Change of prevalence forming the overall bacterial composition before and after neoadjuvant treatment

  About 1 years

• Change of colonization rate (in addition to cyclomodulin-Producing Escherichia Coli) forming the overall bacterial composition before and after neoadjuvant treatment

  About 1 years

• Relative risk of poor response to neoadjuvant treatment in colonized patients with other bacteria ("exposed") compared to non-colonized patients ("unexposed")

  About 1 years

Study Arms (1)

Biological collection

EXPERIMENTAL

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

Interventions

Biological collection OTHER

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

Biological collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III
• Patient is to receive neoadjuvant treatment (radiochemotherapy or chemotherapy or radiotherapy). Induction chemotherapy such as folfox or folfirinox is allowed
• Patient who has signed the informed consent of the study
• Male or female ≥ 18 years old
• 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.

You may not qualify if:

• Antibiotic treatment at the time or in the month preceding stool sampling
• Presence of an ostomy
• Previous treatment for rectal cancer
• Patient not affiliated to a French social protection system
• Patient not in favour of good compliance with treatment for psychological, family, social or geographical reasons
• Legal incapacity (Patient under curatorship or guardianship)
• History of other cancers in the last 5 years (except for in-situ cervical carcinomas and non-melanoma skin carcinomas treated optimally)
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (2)

Institut régional du Cancer de Montpellier

Montpellier, Hérault, 34298, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, Puy De Dôme, 63000, France

NOT YET RECRUITING

Related Publications (17)

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  PMID: 9112145 BACKGROUND

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  PMID: 26705854 BACKGROUND

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• Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; and the GRECCAR Study Group. Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial. Dis Colon Rectum. 2017 Jul;60(7):653-663. doi: 10.1097/DCR.0000000000000849.

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  PMID: 36460331 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Philippe ROUANET, MD

  Institut régional du cancer de Montpellier

  STUDY CHAIR

Central Study Contacts

Aurore MOUSSION, MD

CONTACT

0467612446; Aurore.Moussion@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 25, 2019
• Study Start: January 14, 2020
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2030
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)