NCT03161704已完成不适用
Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 5
- 主要终点
- Collection of up to 3 2cm samples of Endometrial Tissue
研究概览
简要总结
This study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery. The investigators plan to enroll approximately 500 women to validate and optimize the use of genomic classifiers alone or in combination with serum markers (such as cytokines) as a non-surgical marker of disease.
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).
- •Indication for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
排除标准
- 未提供
结局指标
主要结局
Collection of up to 3 2cm samples of Endometrial Tissue
时间窗: 2 collection timepoints: baseline and up to 18 weeks following surgery.
Up to 3 2cm samples will be collected per collection.
次要结局
- Collection of Serum 2 will be 2 7 ml serum tubes of serum(3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.)
- Collection of Serum 1 will be 2 10ml serum tubes of serum(3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.)
研究者
研究点 (5)
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