L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Concentration of L-PGDS in vaginal swabs between groups
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 57 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Aged 28 (≥) to 57 (≤) years.
- •Non-menopausal.
- •Having an indication for a total inter-ovarian hysterectomy (excluding oncology).
- •Suffering from adenomyosis.
- •Adenomyosis - group:
- •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:
- •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.
排除标准
- •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).
研究组 & 干预措施
Patients with adenomyosis (Adenomyosis +)
干预措施: Endometrial ablation (Procedure)
Patients with an endometrial pathology other than adenomyosis (Adenomyosis -)
干预措施: Endometrial ablation (Procedure)
Patients without uterine pathology (control)
结局指标
主要结局
Concentration of L-PGDS in vaginal swabs between groups
时间窗: Day 0
Assessed with immunoenzymatic ELISA (µg/ml)
Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups
时间窗: Day 0
Assessed with immunoenzymatic ELISA (µg/ml) Day 0
次要结局
- Concentration of L-PGDS in blood between groups(7 weeks (range 6 to 8 weeks))
- Concentration of L-PGDS in urine between groups(7 weeks (range 6 to 8 weeks))
- Adenomyosis severity grade(Day 0)
- Concentration of L-PGDS in blood between groups(Day 0)
- Concentration of L-PGDS in urine between groups(Day 0)