The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer

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)

Exclusion criteria

• 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

• 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