Exploring the Molecular and Cellular Composition of Uterine Lavage Specimens Collected at the Time of Gynecologic Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Characterization of cellular composition in uterine lavage fluid
研究概览
简要总结
This study is a designed as a to test the clinical and technical feasibility of using this novel uterine lavage collection catheter to collected UL samples from up to 50 individuals undergoing gynecologic surgery and to describe the cellular composition of these samples. In order to do this, it is a prospective consecutively-enrolled cohort of 50 participants, all of who will receive the intervention of uterine lavage collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing gynecologic surgery with Stanford Healthcare
- •Intact uterus and cervix
- •At least one intact fallopian tube and ovary (on the same side)
- •Aged 18 years or older
- •Ability to understand and the willingness to provide written informed consent.
排除标准
- •Known endometrial or cervical cancer or endometrial or cervical intraepithelial neoplasia
- •Status post bilateral salpingectomy or tubal ligation
- •Lack of consenting capacity
- •Positive preoperative pregnancy test
- •Active uterine bleeding (i.e. menses, etc.)
- •Intrauterine device in place
- •Non-English speaking (requires interpretor)
研究组 & 干预措施
Single Group
Participants undergoing gynecologic surgery who agree to uterine lavage collection intraoperatively for molecular and cellular analysis.
干预措施: Uterine Lavage (Procedure)
结局指标
主要结局
Characterization of cellular composition in uterine lavage fluid
时间窗: At time of gynecologic surgery
Quantification and classification of cell types obtained from uterine lavage specimens using cytology and/or flow cytometry.
Characterization of cellular composition in uterine lavage fluid
时间窗: At time of gynecologic surgery
Quantification and classification of cell types obtained from uterine lavage specimens using cytology and/or flow cytometry.
次要结局
- Molecular profiling of uterine lavage specimens(At time of surgery)
- Detection of inflammatory biomarkers in uterine lavage(At time of surgery)
- Molecular profiling of uterine lavage specimens(At time of surgery)
- Detection of inflammatory biomarkers in uterine lavage(At time of surgery)