Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage
研究概览
简要总结
The goal of this project is to develop a minimally invasive test to detect ovarian cancer, by searching for mutations from the tumor in samples obtained from the cervix (Pap smears), and from the uterus (uterine lavage) in participants with advanced ovarian cancer and in participants with increased risk of ovarian cancer due to inherited mutations, such as BRCA or BRCA2 (among others).
Pap smear and uterine lavage samples will be collected while the participant is under anesthesia for planned debulking surgery. A novel, highly sensitive and accurate technique, Crispr-Duplex sequencing, will be used to detect tumor associated mutations in TP53 (the most commonly mutated gene in ovarian cancer) within these samples. These results will be compared to sequencing results in the tumor itself for comparison, and Pap and uterine lavage will be compared to each other to determine the optimal test. Ultimately, the goal is to use the results of this study to plan a larger study including women without cancer who are at either increased risk or normal risk of ovarian cancer, for use in early detection.
详细描述
OUTLINE:
Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •With suspected advanced ovarian cancer or genetic predisposition to malignant neoplasm of the ovary
- •Planned surgery
- •Have a uterus and no history of tubal occlusion
排除标准
- •Unable to speak English
- •Unable to provide informed consent
- •Prior hysterectomy
结局指标
主要结局
20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage
时间窗: A single point in time after sample collection, no follow-up of participants is done
In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer.
次要结局
未报告次要终点
研究者
Barbara Norquist
Associate Professor
University of Washington
