Exposure to Persistent Organic Pollutants and Severity of Endometriosis in the ComPaRe-Endometriosis Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Blood samples
24mL blood sample (3 dry tubes with 8mL)
Primary outcome measures
- Assessment of the severity of endometriosis, defined by the type of disease. [Time frame: During 3 last years of analysis]
- Evaluation of serum levels of polychlorinated biphenyls (PCBs) [Time frame: 5 months after inclusion start until analysis of the last participant' blood sample]
- Evaluation of serum levels of per- and polyfluoroalkylates (PFAS) [Time frame: 5 months after inclusion start until analysis of the last participant' blood sample]
- Evaluation of serum levels of Brominated flame retardants polluent (BFRs) [Time frame: 5 months after inclusion start until analysis of the last participant' blood sample]
- Evaluation of serum levels of organochlorine pesticides (POCs) [Time frame: 5 months after inclusion start until analysis of the last participant' blood sample]
Secondary outcome measures (3)
- definition of the level of severity of endometriosis by the rASRM stage (revised stage of the American Society for Reproductive Medicine) [Time frame: During 3 last years of analysis]
- definition of the level of severity of endometriosis by the anatomical extension of the disease observed on MRI [Time frame: During 3 last years of analysis]
- endometriosis severity level defined by the severity of painful symptoms. [Time frame: During 3 last years of analysis]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Paris Saint Joseph — Paris
Identifiers
NCT: NCT06973603 · C24-04 · ID-RCB