Testing platelet RNA changes for early ovarian cancer diagnosis

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

This study is testing if changes in blood platelets can help doctors find ovarian cancer earlier in women who have it or have an ovarian mass, compared to healthy women.

Quick facts

• Study type: Observational
• Enrollment: 245 (estimated)
• Ages: 21 Years and up
• Sex: Female
• Sponsor: University of Utah (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT06665945 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include women aged 21 years or older who have been diagnosed with any stage or type of ovarian cancer within the last 8 weeks.

Not a fit: Patients with any other active malignancy or those who have received treatment for cancer within the last 6 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of ovarian cancer, potentially improving patient outcomes.

How similar studies have performed: While this approach is innovative, it builds on previous retrospective analyses that have shown promising results, indicating potential for success.

Eligibility criteria

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 this trial is running

Salt Lake City, Utah

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

Study contacts

• Principal investigator: Theresa Werner, MD — Huntsman Cancer Institute/ University of Utah
• Study coordinator: Syrenna Lisonbee

Conditions Ovarian Cancer