Assessment of Screening Modalities for Gynecologic Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Endometrial Cancer, ovarian cancer
研究概览
简要总结
Background:
- Endometrial and ovarian cancers are, respectively, the fourth and eighth most common cancers among women in the United States. Although some routine Pap tests may detect the presence of cancer cells, there are no convincing early detection approaches for either cancer. Better methods of detection are needed.
- Two possible methods for cancer detection involve samples taken with a tampon or a special kind of brush, called a Tao brush. Researchers would like to know more about how well these methods work.
Objectives:
- To assess the quality of DNA collected by the tampon and Tao brush sampling methods.
- To detect genetic markers in collected DNA and determine if these markers are related to an individual s cancer status.
Eligibility:
- Women age 45 years and older with confirmed or suspected endometrial or ovarian cancer, who will be having surgery.
- A control group of postmenopausal women having surgery for benign gynecological conditions will be included.
Design:
- Shortly before hysterectomy or more extensive procedures to treat either cancer or the benign condition:
- A tampon will be inserted into the vagina to collect cell samples, and removed after 30 minutes.
- After the tampon is removed, the cervix will be swabbed with the Tao brush to collect cell samples.
- Following the hysterectomy, samples of healthy and cancerous tissue will be taken, and tested by researchers.
详细描述
Background:
Currently, there are no convincing early detection approaches for endometrial and ovarian cancers. Although it is well established that some endometrial and ovarian tumors shed cytologically recognizable cells in routinely prepared Pap tests, it is clear that this approach rarely detects occult tumors. Accordingly, efforts to develop means of collecting biological samples that have high patient acceptability, good sensitivity for detecting early disease, and excellent specificity are needed.
Objectives:
In this project, we want to assess the feasibility of using alternative sampling techniques in combination with molecular assays to detect endometrial and ovarian cancers. We will compare sampling using a Tampon and a sheathed endometrial brush, the Tao brush. We want to assess the quality of DNA extracted from the different samplers. We will assess the correlations between methylation of somatic DNA for a selected marker panel and cancer status.
Eligibility:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 120 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Endometrial Cancer, ovarian cancer
时间窗: 1 year
Histologically confirmed endometrial or ovarian cancer
次要结局
未报告次要终点
