The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Early-Stage Ovarian Cancer Detection
研究概览
简要总结
The purpose of the SENTRY (Stability Enhanced Transcriptional Analytics) Study is to test whether combining a unique analytical approach with changes in platelet RNA expression accurately diagnoses ovarian cancer. Using retrospective data, the investigators have developed an approach that appears to accurately classify ovarian cancer with relatively high sensitivity and specificity. The SENTRY Study will build upon these retrospective analyses to prospectively recruit women with ovarian cancer or an ovarian mass (and healthy control women), obtain platelet RNA samples from whole blood, and perform validation analyses to test our hypothesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Study Populations 1 and 2: Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)
- •Inclusion Criteria:
- •Women aged 21 years or older
- •Diagnosed with any type of ovarian or pelvic mass
- •Treatment naïve for current ovarian cancer (if cancer has been diagnosed)
- •The treating medical provider(s) are planning to perform a biopsy, surgery, or other diagnostic procedure to further evaluate the ovarian or pelvic mass (if not already diagnosed prior to consent)
排除标准
- •Any other active malignancy
- •Other diagnosis of any cancer within the last 6 months except for non-melanoma skin cancer or carcinoma in situ of the cervix
- •Treatment for any cancer within the last 6 months except for non-melanoma skin cancer or carcinoma in situ of the cervix. Adjuvant endocrine therapy or other maintenance therapy is allowed.
- •Currently receiving chemotherapy, radiation therapy, or other treatments for ovarian cancer
- •Has already undergone complete ovarian mass resection
- •Unable to provide blood sample
- •Study Population 3: Control Women without Ovarian Cancer (n=30)
- •Inclusion Criteria:
- •1. Women aged 21 years or older
- •Exclusion Criteria:
- •Any active malignancy or diagnosis of cancer within the last 6 months except for non-melanoma skin cancer or carcinoma in situ of the cervix
- •Treatment for any cancer within the last 6 months except for non-melanoma skin cancer or carcinoma in situ of the cervix
- •Hospitalization or surgery (other than minor surgery such as mole removal) within the last 8 weeks
- •Renal failure (defined as eGFR < 60 mL/min/1.73m² or on dialysis)
- •Liver failure (defined as having hepatic encephalopathy of any degree, OR moderately severe coagulopathy defined as INR ≥ 1.5, OR known cirrhosis, OR ALT of ≥ 10X ULN, OR total bilirubin of ≥ 3.0 mg/dL, OR diagnosis of liver failure)
- •Decompensated or end-stage heart failure (defined as ACC/AHA Stage C or Stage D heart failure)
- •Poorly controlled diabetes mellitus (defined as a HbA1c > 9.0%)
- •Venous thrombosis, myocardial infarction, or stroke within the last 8 weeks
- •Currently pregnant or have been pregnant within the last 12 weeks
- •Any blood product transfusion within the last 8 weeks
- •Personal history of ovarian cancer at any time
- •History of bilateral salpingo-oophorectomy
- •History of oophorectomy
- •Unable to provide blood sample
研究组 & 干预措施
Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)
干预措施: Platelet RNA expression (Diagnostic Test)
Control Women without Ovarian Cancer (n=30)
干预措施: Platelet RNA expression (Diagnostic Test)
结局指标
主要结局
Early-Stage Ovarian Cancer Detection
时间窗: Following informed consent (study visit 1, day 1).
The goal is to determine if changes in platelet RNA expression accurately diagnoses ovarian cancer. This outcome will report the number of true positive, true negative, false positive, and false negative results from this assay.
次要结局
未报告次要终点