Actively Recruiting
Effects of Endocrine Disruptors on the Gut Microbiota and Their Impact on Colorectal Cancer Development
Led by Poitiers University Hospital · Updated on 2025-02-13
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
P
Poitiers University Hospital
Lead Sponsor
U
University of Poitiers - Laboratoire Ecologie et Biologie des Interactions (EBI) - UMR CNRS 7267
Collaborating Sponsor
AI-Summary
What this Trial Is About
Colorectal cancer is a major health concern worldwide and was the second leading cause of cancer-related deaths in 2020. This research aims to study the relationship between colorectal cancer diagnosis, the activity and composition of the gut microbiota, and patients' exposure to certain endocrine disruptors, specifically parabens and phthalates. These substances, commonly found in water and food, may affect gut microorganisms and potentially influence the development of colorectal cancer. This pilot study is conducted at a single center using a descriptive and comparative design involving two groups: 100 patients diagnosed with colorectal cancer and 100 control patients without suspected colorectal cancer. Each participant will provide stool, hair, and urine samples, and complete a questionnaire about their exposure to endocrine disruptors. The inclusion period lasts 48 months, with each participant enrolled for up to one month. Routine care data will be collected for five years, making the total study duration about nine years. Participants will undergo sample collection and complete questionnaires to assess exposure to endocrine disruptors and analyze gut microbiota composition. Researchers will evaluate the association between fecal microbiota disruption and endocrine disruptor exposure, along with related microbiota and metabolome characteristics. The primary outcome is measured within one month per patient. Data on exposome, gut bacteria differences, and correlations with colorectal cancer will be gathered, with safety and follow-up continuing throughout the long-term study period.
CONDITIONS
Brief Title
Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development (PERMICA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled endoscopy during the inclusion visit or within 18 months following this consultation
- Signed consent after clear and fair information about the study
- Patient is free of guardianship, curatorship, or dependency
- Covered by a social security system or a third party
You will not qualify if you...
- Receiving treatment for chronic inflammatory bowel disease
- Having hereditary colorectal cancer
- Use of antibiotics, probiotics, or prebiotics within four weeks prior to stool sample collection
- Undergoing neoadjuvant chemotherapy or radiotherapy
- Previous surgical resection
- Under enhanced protection (minors, individuals deprived of liberty, residing in healthcare or social institutions, adults under legal protection)
- Pregnant or breastfeeding women
- Use of antibiotics, probiotics, or prebiotics before stool collection during study participation
- Endoscopy not performed within 18 months following inclusion
- Failure to send or receive stool samples
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 18 months before stool sample collection
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 1 month from enrollment
Participants provide biological samples including hair, urine, and stool, and complete an endocrine disruptor exposure questionnaire.
1 visit for sample collection and questionnaire completion
Duration - 5 years
Participants' routine care data are collected over 5 years to observe health outcomes related to colorectal cancer and exposure to endocrine disruptors.
Routine care visits as per normal healthcare without additional trial visits
Trial Site Locations
Total: 1 location
1
CHU de Poitiers
Poitiers, France, 86000
Actively Recruiting
Research Team
V
Violaine RANDRIAN, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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