NCT03485651终止不适用
Prospective Collection of Samples for Development of the Natera Ovarian Cancer Detection Assay
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Natera, Inc.
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Compare ctDNA from benign ovarian masses and confirmed ovarian cancers
研究概览
简要总结
The purpose of this study is to enroll participants who present with an adnexal mass on imaging to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses. The study will collect blood, tissue, and health information from these individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Presenting to clinic with adnexal mass suspicious of ovarian, fallopian tube, or peritoneal cancer on imaging
- •Must be planning surgical resection or biopsy
- •Must be treatment naïve
- •Must be 18 years or older
- •Able to understand and sign a written informed consent document
- •Able to provide 40mL of blood (at least 20mL) for each blood draw
排除标准
- •Prior removal of either ovary for any reason
- •Currently pregnant
- •Blood transfusion within 3 months of study enrollment
- •History of bone marrow or organ transplant
- •Prior history and treatment for any malignancy, with exception of previously treated non-melanoma skin cancer.
- •A medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia
结局指标
主要结局
Compare ctDNA from benign ovarian masses and confirmed ovarian cancers
时间窗: Up to 60 months or 5 years
Examine ctDNA between benign ovarian masses and confirmed ovarian cancer cases (based on tumor pathology report). The purpose of this outcome is to determine whether cfDNA could be used to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses.
次要结局
- Determine the relationship between quantity of ctDNA and standard prognostic criteria(Up to 60 months or 5 years)
研究者
研究点 (1)
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