Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development (PERMICA)

NCT06809660 | Recruiting

• 1 other identifier: 2024-A02197-40
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the third most common cancer worldwide, yet it was the second leading cause of cancer-related deaths in 2020. The average French population faces a colorectal cancer risk partly linked to lifestyle factors. The majority of colorectal cancer cases (approximately 85%) are not caused by hereditary mutations. Environmental factors, such as lifestyle or diet (notably through endocrine disruptors), can affect the gut microbiota (a collection of microorganisms - bacteria, viruses, parasites, and fungi - residing in the intestinal environment) and lead to disturbances in its composition, referred to as dysbiosis. While the mechanisms underlying dysbiosis associated with colorectal cancer remain poorly understood, the involvement of certain ingested substances, known as xenobiotics, is increasingly suspected, including endocrine disruptors. Among the most common endocrine disruptors found in water and food are parabens and phthalates, which will be examined in detail in this study. These substances may be directly involved in the development of colorectal cancer and in response to its treatment. The main objective of this studie is to characterize the relationship between colorectal cancer diagnosis, activity/composition of the gut microbiota, and patients' exposure to selected endocrine disruptors, particularly parabens and phthalates.

Conditions

Colorectal Cancer (CRC); Endocrine Disruptors; Microbiota; Dysbiosis

Outcome Measures

Primary Outcomes (1)

• Association between faecal microbiota disruption and exposure to endocrine disruptors

  Association between disruptions in the composition and/or activity of the faecal microbiota (sequencing and metabolome analysis) and exposure to endocrine disruptors (measured in urine and stool samples) in patients with colorectal cancer and in controls

  1 month/patient (maximum time between enrolment visit and stool collection)

Secondary Outcomes (4)

• Describe the accumulated exposome

  1 day/patient

• Describe gut microbiota composition

  1 month/patient (maximum time between enrolment visit and stool collection)

• Detect differences in pro-carcinogenic bacteria

  1 month/patient (maximum time between enrolment visit and stool collection)

• Correlation metabolome / gut microbiota in patients with colorectal cancer

  1 month/patient (maximum time between enrolment visit and stool collection)

Study Arms (2)

Patient with colorectal cancer

OTHER

Other: Collection of biological samples and clinical data

Patient without suspected colorectal cancer

OTHER

Other: Collection of biological samples and clinical data

Interventions

Collection of biological samples and clinical data OTHER

* Collection of a hair sample * Collection of urine * Collection of stool samples * Collection of clinical, paraclinical data, and exposure questionnaire

Patient with colorectal cancer; Patient without suspected colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed consent from the patient after clear and fair information about the study is provided.
• Patient is free of guardianship, curatorship, or dependency.
• Patient is covered by a social security system or through a third party.

You may not qualify if:

• Patients receiving treatment for chronic inflammatory bowel disease;
• Patients with hereditary colorectal cancer;
• Use of antibiotics, probiotics, or prebiotics within four weeks prior to stool sample collection;
• Patients who have undergone neoadjuvant chemotherapy or radiotherapy;
• Patients who have had previous surgical resection;
• Patients under enhanced protection: minors, individuals deprived of liberty by judicial or administrative decision, individuals residing in healthcare or social institutions, and adults under legal protection;
• Pregnant and/or breastfeeding women.
• Patients presenting any of the following during their participation in the study will be excluded:
• Failure to send/receive stool samples

Sponsors & Collaborators

• Poitiers University Hospital: lead
• University of Poitiers - Laboratoire Ecologie et Biologie des Interactions (EBI) - UMR CNRS 7267: collaborator

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Dysbiosis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Violaine RANDRIAN, Doctor

CONTACT

00335 49 44 42 93; violaine.randrian@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): January 21, 2031
• Study Completion (Estimated): January 21, 2034
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)