Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay
Recruiting · NCT06864494 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centre Hospitalier Universitaire de Nīmes
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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).
Where it is running
1 location listed.
- CHU de Nimes - Nîmes, France