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

Methodology:

Pilot, single-center regional study, with a descriptive and comparative design (patients with colorectal cancer / patients without suspected colorectal cancer = controls).

In each group, a stool, hair and urine sample will be collected and an endocrine disruptor exposure questionnaire completed.

Sample Size and Duration:

A total of 200 patients will be included, divided into two groups of 100 patients (100 patients with colorectal cancer and 100 patients without suspected colorectal cancer). The inclusion period will last 48 months, with each participant enrolled for a maximum of one month. Routine care data will be collected over 5 years. The total duration of the clinical investigation will be approximately 9 years.

Expected Outcomes:

The investigators aim at determining whether the most common endocrine disruptors in the French population are involved in colorectal carcinogenesis and if these substances are correlated with dysbiotic colorectal microbiota.

The findings from this study should help identify the endocrine disruptors most frequently associated with colorectal cancer and thereby enhance vigilance regarding these substances.

Benefits for Patients:

There are no individual but collective benefits, as the results will colorectal cancer related knowledge and its relationship with lifestyle.

Inclusion criteria

• Scheduled endoscopy during the inclusion visit or within 18 months following this consultation.
• 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.

Exclusion criteria

• 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.

Exclusion criteria

During Study Participation:

• Patients presenting any of the following during their participation in the study will be excluded:
• Use of antibiotics, probiotics, or prebiotics before stool collection (between inclusion and stool collection, which may occur within the month);
• Endoscopy not performed within 18 months following inclusion;
• Failure to send/receive stool samples