The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of O
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
| Condition(s) | Ovarian Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 21 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Utah |
| Locations | Salt Lake City, Utah, United States |
| Start date | 2025-04-15 |
| NCT ID | NCT06665945 |
| Official listing | https://clinicaltrials.gov/study/NCT06665945 |