Exposure to Persistent Organic Pollutants and Severity of Endometriosis in the ComPaRe-Endometriosis Cohort

NCT06973603 | Not Yet Recruiting

• 2 other identifiers: C24-04ID-RCB
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

exposition; Endometriosis; Organic Persistent Polluant; Endometriosis severity; endomestriosis symptoms; endometriosis pain

Outcome Measures

Primary Outcomes (5)

• Assessment of the severity of endometriosis, defined by the type of disease.

  Analysis of several online questionnaires on endometriosis by participants

  During 3 last years of analysis

• Evaluation of serum levels of polychlorinated biphenyls (PCBs)

  Chemical analysis of participants' blood samples by the LABERCA laboratory

  5 months after inclusion start until analysis of the last participant' blood sample

• Evaluation of serum levels of per- and polyfluoroalkylates (PFAS)

  Chemical analysis of participants' blood samples by the LABERCA laboratory

  5 months after inclusion start until analysis of the last participant' blood sample

• Evaluation of serum levels of Brominated flame retardants polluent (BFRs)

  Chemical analysis of participants' blood samples by the LABERCA laboratory

  5 months after inclusion start until analysis of the last participant' blood sample

• Evaluation of serum levels of organochlorine pesticides (POCs)

  Chemical analysis of participants' blood samples by the LABERCA laboratory

  5 months after inclusion start until analysis of the last participant' blood sample

Secondary Outcomes (3)

• definition of the level of severity of endometriosis by the rASRM stage (revised stage of the American Society for Reproductive Medicine)

  During 3 last years of analysis

• definition of the level of severity of endometriosis by the anatomical extension of the disease observed on MRI

  During 3 last years of analysis

• endometriosis severity level defined by the severity of painful symptoms.

  During 3 last years of analysis

Interventions

Blood samples OTHER

24mL blood sample (3 dry tubes with 8mL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hôpital Paris Saint Joseph

Paris, 75014, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

24mL blood sample (3 dry tubes with 8mL)

MeSH Terms

Conditions

Endometriosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• MARINA Kvaskoff, Dr

  Hôpital Paul Brousse

  STUDY DIRECTOR

Central Study Contacts

Frédérique Perrotte, Principal investigator

CONTACT

01 44 12 38 31; fperrotte@ghpsj.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-05

Locations

FR (1)