Clinical trial NCT06973603: Exposure to Persistent Organic Pollutants and Severity of Endometriosis in the ComPaRe-Endometriosis Cohort
Official title: Exposure to Persistent Organic Pollutants and Severity of Endometriosis in the ComPaRe-Endometriosis Cohort
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometriosis
Keywords: exposition
Endometriosis
Organic Persistent Polluant
Endometriosis severity
endomestriosis symptoms
endometriosis pain
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2025-05-15
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be a group of female volunteers who have self-reported endometriosis. The group size will be a random sample of 650 women from the \~10,000 participants included in the ComPaRe-Endometriosis sub-cohort.

Brief summary: Endometriosis is a chronic inflammatory disease affecting \~10% of women of childbearing age. It is characterized by the presence of endometrial-like tissue outside the uterus, causing lesions and adhesions between the organs, and is often accompanied by intense pain and sometimes infertility. The four-stage classification based on the severity of lesions does not always reflect the severity of symptoms. Adenomyosis, a similar pathology, is often present in the same patients, although it is now considered distinct from endometriosis. Diagnosis usually takes a long time, with an average delay of 7 years. The cause of the disease remains unknown, but hormonal, genetic and environmental factors, such as exposure to endocrine disruptors, are suspected. Persistent organic pollutants (POPs), such as dioxins and PCBs, may influence the risk and severity of the disease. Although experimental studies suggest a link between these substances and the progression of endometriosis, epidemiological research on the subject is still limited.

The central hypothesis of the POPENDO project is that higher concentrations of persistent organic pollutants (POPs) are associated with increased severity of endometriosis. The aim of the study is to explore the associations between serum levels of four families of POPs (PCBs, organochlorine pesticides, PFAS and BFR) and endometriosis.


Eligibility criteria: Inclusion Criteria:

* ComPaRe participants ⩾ 18 years old. All ComPaRe participants are at least 18 years of age, so our research participants will all be adults.
* Having declared in ComPaRe that they had endometriosis
* Living in the Ile-de-France region (departments 75, 77, 78, 91, 92, 93, 94 or 95);
* Have given electronic consent stating: "By checking this box, I agree to be solicited for research outside ComPaRe"; This criterion is collected at the time of ComPaRe registration, when consent is collected. Participants can withdraw this consent at any time on their secure personal online account on the ComPaRe platform.
* Aged ≤ 45 years to avoid including premenopausal or menopausal women;
* In possession of MRI images used to diagnose their endometriosis (CD-ROM) that are no more than 5 years old;
* Enrolled in or benefiting from a social security scheme.

Exclusion Criteria:

* - People with contraindications to blood sampling will not be included in this research:
* Known severe anemia
* Hemophilia/coagulation disorders/anticoagulant use
* People with HIV, HBV or HCV will not be included in this study due to the risk of BSE (Blood Exposure Accident).
* Based on factors that may disrupt lipid dynamics and lipid pollutants, the following individuals will not be included:
* Pregnant and breast-feeding women
* People suffering from any of the following diseases:

  * Cancer
  * Morbid obesity (BMI\>40)
  * Non-alcoholic steatohepatitis (NASH)
* Persons under court protection/guardianship/guardianship will not be able to participate in this research.

Primary outcomes:
measure: Assessment of the severity of endometriosis, defined by the type of disease.
timeFrame: During 3 last years of analysis
measure: Evaluation of serum levels of polychlorinated biphenyls (PCBs)
timeFrame: 5 months after inclusion start until analysis of the last participant' blood sample
measure: Evaluation of serum levels of per- and polyfluoroalkylates (PFAS)
timeFrame: 5 months after inclusion start until analysis of the last participant' blood sample
measure: Evaluation of serum levels of Brominated flame retardants polluent (BFRs)
timeFrame: 5 months after inclusion start until analysis of the last participant' blood sample
measure: Evaluation of serum levels of organochlorine pesticides (POCs)
timeFrame: 5 months after inclusion start until analysis of the last participant' blood sample
Secondary outcomes:
measure: definition of the level of severity of endometriosis by the rASRM stage (revised stage of the American Society for Reproductive Medicine)
timeFrame: During 3 last years of analysis
measure: definition of the level of severity of endometriosis by the anatomical extension of the disease observed on MRI
timeFrame: During 3 last years of analysis
measure: endometriosis severity level defined by the severity of painful symptoms.
timeFrame: During 3 last years of analysis
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
Study officials:
affiliation: Hôpital Paul Brousse
name: MARINA Kvaskoff, Dr
role: STUDY_DIRECTOR
References: