Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Poitiers - Laboratoire Ecologie et Biologie des Interactions (EBI) - UMR CNRS 7267 | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with colorectal cancer | Other |
| |
| Patient without suspected colorectal cancer | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of biological samples and clinical data | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month/patient (maximum time between enrolment visit and stool collection) |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the accumulated exposome | LC/MS on hair samples | 1 day/patient |
| Describe gut microbiota composition | From stool samples | 1 month/patient (maximum time between enrolment visit and stool collection) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria During Study Participation:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Violaine RANDRIAN, Doctor | Contact | 00335 49 44 42 93 | violaine.randrian@chu-poitiers.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Poitiers | Recruiting | Poitiers | 86000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Detect differences in pro-carcinogenic bacteria | In stool samples | 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 | 1 month/patient (maximum time between enrolment visit and stool collection) |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided