Colorectal Cancer (CRC)PERMICANCT06809660
Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development (PERMICA)
A study testing Collection of biological samples and clinical data in people with Colorectal Cancer (CRC) and Endocrine Disruptors, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC), Endocrine Disruptors, Microbiota
- What is being tested?
- Collection of biological samples and clinical data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2025to 21 Jan 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Failure to send/receive stool samples
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Poitiers
Poitiers, 86000
Violaine RANDRIAN, Doctor, 00335 49 44 42 93, violaine.randrian@chu-poitiers.fr
About this study
Official title: Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer (CRC), Endocrine Disruptors, Microbiota, Dysbiosis
- Being tested
- Collection of biological samples and clinical data
- Medical subject headings
- Colorectal Neoplasms, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samples and clinical dataOther
- Collection of a hair sample
- Collection of urine
- Collection of stool samples
- Collection of clinical, paraclinical data, and exposure questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patient with colorectal cancer | Other | Not described Receives: Other: Collection of biological samples and clinical data |
| Patient without suspected colorectal cancer | Other | Not described Receives: Other: Collection of biological samples and clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month/patient (maximum time between enrolment visit and stool collection)
Secondary outcomes (4)
Describe the accumulated exposome
LC/MS on hair samples
Measured: 1 day/patient
Describe gut microbiota composition
From stool samples
Measured: 1 month/patient (maximum time between enrolment visit and stool collection)
Detect differences in pro-carcinogenic bacteria
In stool samples
Measured: 1 month/patient (maximum time between enrolment visit and stool collection)
Correlation metabolome / gut microbiota in patients with colorectal cancer
Analysis of the correlation between the metabolome and gut microbiota in colorectal cancer patients
Measured: 1 month/patient (maximum time between enrolment visit and stool collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start21 Jan 2025
- Primary completion21 Jan 2031 (estimated)
- Study completion21 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Poitiers - Laboratoire Ecologie et Biologie des Interactions (EBI) - UMR CNRS 7267
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809660
- Sponsor's protocol ID
- 2024-A02197-40
- Acronym
- PERMICA
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development
- ClinicalTrials.gov ID
- NCT06809660
- Acronym / sponsor ID
- PERMICA / 2024-A02197-40
- Conditions
- Colorectal Cancer (CRC), Endocrine Disruptors, Microbiota, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- University of Poitiers - Laboratoire Ecologie et Biologie des Interactions (EBI) - UMR CNRS 7267
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 21 Jan 2031 (estimated)
- Study completion
- 21 Jan 2034 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological samples and clinical data* Collection of a hair sample * Collection of urine * Collection of stool samples * Collection of clinical, paraclinical data, and exposure questionnaire | Other | Patient with colorectal cancer, Patient without suspected colorectal cancer |
Primary outcome
Association between faecal microbiota disruption and exposure to endocrine disruptors
Time frame: 1 month/patient (maximum time between enrolment visit and stool collection)
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
4 secondary outcomes
Describe the accumulated exposome
Time frame: 1 day/patient
Describe gut microbiota composition
Time frame: 1 month/patient (maximum time between enrolment visit and stool collection)
Detect differences in pro-carcinogenic bacteria
Time frame: 1 month/patient (maximum time between enrolment visit and stool collection)
Correlation metabolome / gut microbiota in patients with colorectal cancer
Time frame: 1 month/patient (maximum time between enrolment visit and stool collection)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of biological samples and clinical data in people with Colorectal Cancer (CRC) and Endocrine Disruptors, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Violaine RANDRIAN, Doctor (00335 49 44 42 93, violaine.randrian@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between faecal microbiota disruption and exposure to endocrine disruptors (time frame: 1 month/patient (maximum time between enrolment visit and stool collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.