NCT06809660Recruiting
Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development (PERMICA)
Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 21 Jan 2025
- Primary completion date
- 21 Jan 2031
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06809660
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 21 Jan 2025 to the primary completion date, 21 Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving treatment for chronic inflammatory bowel disease;
- 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;
Other illness
- Patients with hereditary colorectal cancer;
- Failure to send/receive stool samples
Other
- 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:
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.