L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups. (ADENO-L)

NCT06864494 RECRUITING

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).

Details

Lead sponsor	Centre Hospitalier Universitaire de Nīmes
Status	RECRUITING
Enrolment	60
Start date	2025-06-25
Completion	2027-06

Conditions

• Adenomyosis
• Endometriosis

Interventions

• Endometrial ablation

Primary outcomes

• Concentration of L-PGDS in vaginal swabs between groups — Day 0
  Assessed with immunoenzymatic ELISA (µg/ml)
• Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups — Day 0
  Assessed with immunoenzymatic ELISA (µg/ml) Day 0

Countries

France