Testing platelet RNA changes for early ovarian cancer diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SENTRY Study aims to evaluate whether changes in platelet RNA expression can improve the early diagnosis of ovarian cancer. By prospectively recruiting women diagnosed with ovarian cancer or an ovarian mass, as well as healthy controls, the study will collect platelet RNA samples from whole blood. The investigators will then perform validation analyses to assess the accuracy of their unique analytical approach, which has shown promise in retrospective data. This study seeks to enhance diagnostic sensitivity and specificity for ovarian cancer.

Why it matters

Who can join: the full rules

Study Populations 1 and 2: Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)

Inclusion Criteria:

1. Women aged 21 years or older
2. Diagnosed with any type of ovarian or pelvic mass
3. Treatment naïve for current ovarian cancer (if cancer has been diagnosed)
4. 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:

1. Any other active malignancy
2. Other diagnosis of any cancer within the last 6 months except for non-melanoma skin cancer or carcinoma in situ of the cervix
3. 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.
4. Currently receiving chemotherapy, radiation therapy, or other treatments for ovarian cancer
5. Has already undergone complete ovarian mass resection
6. 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:

1. 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
2. Treatment for any cancer within the last 6 months except for non-melanoma skin cancer or carcinoma in situ of the cervix
3. Hospitalization or surgery (other than minor surgery such as mole removal) within the last 8 weeks
4. Renal failure (defined as eGFR \< 60 mL/min/1.73m² or on dialysis)
5. 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)
6. Decompensated or end-stage heart failure (defined as ACC/AHA Stage C or Stage D heart failure)
7. Poorly controlled diabetes mellitus (defined as a HbA1c \> 9.0%)
8. Venous thrombosis, myocardial infarction, or stroke within the last 8 weeks
9. Currently pregnant or have been pregnant within the last 12 weeks
10. Any blood product transfusion within the last 8 weeks
11. Personal history of ovarian cancer at any time
12. History of bilateral salpingo-oophorectomy
13. History of oophorectomy
14. Unable to provide blood sample

Where it's running

• Huntsman Cancer Institute
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Theresa Werner, MD — Huntsman Cancer Institute
• Study coordinator: Syrenna Lisonbee
• Email: Syrenna.Lisonbee@hci.utah.edu
• Phone: 801-585-0161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.