Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Dysbiosis | — | UNRESOLVED | — |
| Endocrine Disruptors | — | UNRESOLVED | — |
| Microbiota | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of biological samples and clinical data | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Patient with colorectal cancer
- interventionNames
- Other: Collection of biological samples and clinical data
- type
- OTHER
- label
- Patient without suspected colorectal cancer
- interventionNames
- Other: Collection of biological samples and clinical data
Primary outcomes (1)
- measure
- Association between faecal microbiota disruption and exposure to endocrine disruptors
- timeFrame
- 1 month/patient (maximum time between enrolment visit and stool collection)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available