Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- S1PR1 levels in PBLs with and without endometriosis.
研究概览
简要总结
Patients seen at the SLUCare Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum will be excised (removed).
After surgical excision has been performed, in order to provide standardized specimens for our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3 mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue will be sent to histology (SSM) for evaluation and classification as having endometriosis or not. For each patient in the study, blood will also be collected to look for markers for endometriosis.
详细描述
The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for endometriosis on patients presenting with pain, infertility or both will be performed by the principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative and postoperative follow-up data on all patients recruited for this study based on comprehensive preoperative questionnaires, which includes data collection on pain scores (by VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The surgical approach in the treatment of endometriosis is by excision only, so that all lesions (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified at a histologic level, which is the gold standard way to diagnose the presence of endometriosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients seen at the Center for Endometriosis (including those with or without pain) who are undergoing excision surgery.
- •Patients who are undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
- •Completed a preoperative questionnaire
排除标准
- •prior bilateral salpingo-oophorectomy
- •post natural menopause
结局指标
主要结局
S1PR1 levels in PBLs with and without endometriosis.
时间窗: At Surgery
To determine if S1PR1 levels in PBLs can discriminate between patients with endometriosis and patients without endometriosis.
次要结局
未报告次要终点
研究者
Patrick Yeung Jr., MD
MD
St. Louis University