Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Positive predictive value (PPV) of ovarian cancer screening
研究概览
简要总结
The present investigation will prospectively evaluate whether serial transvaginal ultrasonography with Morphology Index (MI) can further reduce false positive results by more accurately distinguishing benign from malignant ovarian tumors. If there is no change in the detection of true positive cases, the result will be an increase in the positive predictive value of ovarian cancer screening.
详细描述
Primary Objective:
To determine if a treatment algorithm using serial transvaginal ultrasound with a tumor morphology index can improve the positive predictive value (PPV) of ovarian cancer screening compared to a historical control from 15% to 25%.
Secondary Objective To measure the compliance for study participants enrolled on the treatment algorithm using serial transvaginal ultrasound with a tumor morphology index.
Exploratory Objective To determine the effectiveness of a treatment algorithm that combines serum biomarkers aloneor in combination with transvaginal ultrasound to reduce the false positive rate of ovarian cancer screening in the subset of women agreeing to biomarker 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women must be enrolled in the University of Kentucky Ovarian Cancer Screening Program Eligibility criteria for the OCSP are: 50 years of age or older, or be postmenopausal and have not had a prior salpingo-oophorectomy or have a family history of ovarian cancer in a primary relative or have a self-history of breast cancer.
- •Patients have a documented ovarian abnormality on ultrasound
- •Patients having undergone prior hysterectomy will be eligible provided that they meet the other requirements for entry into this study.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who are not enrolled in the University of Kentucky Ovarian Cancer Screening Program .
- •Patients who cannot tolerate the vaginal ultrasound procedure.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients who are referred with pelvic symptoms, a known pelvic mass, or a history of prior radiation, will be excluded from this investigation.
- •History of ovarian cancer.
- •Prior bilateral salpingo-oophorectomy.
- •Prisoners.
- •Women who are currently pregnant.
结局指标
主要结局
Positive predictive value (PPV) of ovarian cancer screening
时间窗: Up to 12 months
Whether the treatment algorithm for patients with abnormal ultrasounds improves the positive predictive value of ultrasounds as ovarian screening tests, thus lowering the false positive rate compared to historical controls.
次要结局
- Surgical complications(Up to 12 months)
- Compliance to the treatment algorithm(Up to 12 months)
研究者
Frederick R. Ueland, M.D.
Principal Investigator
University of Kentucky