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

Обзор

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.

Вмешательства

• Другое Blood samples
  24mL blood sample (3 dry tubes with 8mL)

Первичные конечные точки

• Assessment of the severity of endometriosis, defined by the type of disease. [Срок оценки: During 3 last years of analysis]
• Evaluation of serum levels of polychlorinated biphenyls (PCBs) [Срок оценки: 5 months after inclusion start until analysis of the last participant' blood sample]
• Evaluation of serum levels of per- and polyfluoroalkylates (PFAS) [Срок оценки: 5 months after inclusion start until analysis of the last participant' blood sample]
• Evaluation of serum levels of Brominated flame retardants polluent (BFRs) [Срок оценки: 5 months after inclusion start until analysis of the last participant' blood sample]
• Evaluation of serum levels of organochlorine pesticides (POCs) [Срок оценки: 5 months after inclusion start until analysis of the last participant' blood sample]

Вторичные конечные точки (3)

• definition of the level of severity of endometriosis by the rASRM stage (revised stage of the American Society for Reproductive Medicine) [Срок оценки: During 3 last years of analysis]
• definition of the level of severity of endometriosis by the anatomical extension of the disease observed on MRI [Срок оценки: During 3 last years of analysis]
• endometriosis severity level defined by the severity of painful symptoms. [Срок оценки: During 3 last years of analysis]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• \- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Hôpital Paris Saint Joseph — Paris

Идентификаторы

NCT: NCT06973603 · C24-04 · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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