NCT06864494 Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay
| NCT ID | NCT06864494 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Adenomyosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-06-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prostaglandin D2 (PGD2) has anti-inflammatory activity, particularly via Lipocalin type-prostaglandin (L-PGDS). L-PGDS has been studied in pathologies such as sleep apnea, rheumatoid arthritis, asthma and allergic phenomena, but never in adenomyosis. Adenomyosis is a estrogen-dependent multifactorial pathology whose pathophysiology is still poorly defined. This hyperestrogenism causes chronic inflammation, particularly via the activation of the prostaglandin H2 (PGH2) signaling pathway. This would lead to the excess production of prostaglandins E2 (PGE2) and F2a (PGF2a) and the decrease of PGD2 and therefore of L-PGDS, leading to the proliferation of endometrial cells in the myometrium by the epithelial-mesenchymal transition via aromatase. A preliminary study comparing the expression of L-PGDS found a significant decrease in L-PGDS in the uterus of women with adenomyosis lesions versus healthy controls. However, during this study, some information was not collected, including the patients' symptoms, preoperative radiological data and surgical indication. The study authors hypothesize that L-PGDS could be a potential tissue and circulating diagnostic marker of adenomyosis in its early stages. L-PGDS appears to be a good candidate to aid in the diagnosis of adenomyosis via a minimally invasive assay for patients (blood or urine).
Eligibility Criteria
Inclusion Criteria: Common inclusion criteria: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Adenomyosis + group: * Female. * Aged 28 (≥) to 57 (≤) years. * Non-menopausal. * Having an indication for a total inter-ovarian hysterectomy (excluding oncology). * Suffering from adenomyosis. Adenomyosis - group: * Female. * Aged 28 (≥) to 57 (≤) years. * Non-menopausal. * Having an indication for a total inter-ovarian hysterectomy (excluding oncology). * Suffering from a functional pathology other than adenomyosis. Control Group: * Female. * Aged 18 (≥) to 57 (≤) years. * Asymptomatic: absence of menometrorrhagia and pelvic pain. * Support at the medically assisted procreation (MAP) center of the Nîmes University Hospital for male or idiopathic infertility. * Indication to perform an endovaginal ultrasound as part of MAP management. * Absence of uterine pathology visualized on endovaginal ultrasound. Exclusion Criteria: * History of autoinflammatory or autoimmune disease. * History of atopic or asthmatic conditions. * History of sleep apnea syndrome. * Chronic or acute renal failure. * Liver failure * History of active neoplasia or cancer. * Taking nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or aspirin in the 15 days prior to L-PGDS concentration measurement * Undergoing estrogen-progestin hormonal contraception. Adenomyosis groups: \- Contraindication to MRI. Control Group: * Endovaginal ultrasound refused by the patient. * Presence of a functional-looking ovarian cyst on imaging (endovaginal ultrasound and/or pelvic MRI).
Contact & Investigator
Stéphanie HUBERLANT
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Frequently Asked Questions
Who can join the NCT06864494 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 57 Years, studying Adenomyosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864494 currently recruiting?
Yes, NCT06864494 is actively recruiting participants. Contact the research team at stephanie.huberlant@chu-nimes.fr for enrollment information.
Where is the NCT06864494 trial being conducted?
This trial is being conducted at Nîmes, France.
Who is sponsoring the NCT06864494 clinical trial?
NCT06864494 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Stéphanie HUBERLANT at Centre Hospitalier Universitaire de Nīmes. The trial plans to enroll 60 participants.