Whole Blood Collection Protocol For Ovarian Assay Clinical Trial In Women With Ovarian Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 36
- 主要终点
- Proportion of actual ovarian cancer cases among OvaRl positive patients is higher than the proportion of actual ovarian cancer cases among referred patients.
研究概览
简要总结
Purpose
The OvaRI assay clinical trial is directed at evaluating a novel proteomics-based blood test. This test is for a physician to use towards differentiating benign from malignant ovarian tumors prior to surgical intervention. Tools that can better triage women with an ovarian tumor are needed. It has been shown that women with ovarian cancer who are referred to gynecologic oncologists have better outcomes. The primary objective of this study is to demonstrate that the OvaRl assay (test) improves the preoperative identification of ovarian cancer in patients with a ovarian tumor.
详细描述
Study Design This is a multi-center study including low and high prevalence ovarian cancer sites. The sites are representative of all institutions where potential ovarian tumor subjects will undergo a gynecological examination with radiological exam prior to surgical intervention. A blood specimen will be taken once only from enrolled subjects. This blood specimen will be used in the evaluation of the OvaRl test to identify subjects with ovarian cancer from within a population of women with a documented ovarian mass and planned surgical intervention.
Expected Total Enrollment: Up to 1000 subjects with a documented ovarian mass Study Start: February 2007
Study Details:
Study Population:
Female subjects over the age of 18 with an ovarian tumor with planned surgical intervention will be enrolled at up to 40 sites. The sites will be demographically mixed to include, for example, large and small medical centers (universities/community hospitals), small gynecology/obstetrics groups, gynecology/oncology practices, and HMO groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subject is female and age 18 years or older
- •Subject has a level of understanding sufficient to agree to all tests required by the protocol, must be considered reliable and must be able to cooperate with study procedures
- •Subject signs approved written informed consent prior to any study procedures being performed
- •Subject must agree to venipuncture
- •Subject has a documented adnexal tumor with planned surgical intervention
排除标准
- •Women under age 18
- •No planned surgical intervention
- •Decline phlebotomy
- •Diagnosis of malignancy in the last 10 years, with the exception of a non-melanoma skin cancer
结局指标
主要结局
Proportion of actual ovarian cancer cases among OvaRl positive patients is higher than the proportion of actual ovarian cancer cases among referred patients.
次要结局
- Evaluate OvaRl assay plus standard clinical practice.