NCT06665945Recruiting
The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 245 (estimated)
- First submitted
- 11 Sept 2024
- Start date
- 15 Apr 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- University of Utah
- Diseases
- Ovarian cancer
- NCT number
- NCT06665945
What you commit to
- Study type: Observational
- Planned participants: 245
- From 15 Apr 2025 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving chemotherapy, radiation therapy, or other treatments for ovarian cancer
- Has already undergone complete ovarian mass resection
- Hospitalization or surgery (other than minor surgery such as mole removal) within the last 8 weeks
Other illness
- 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.
- Unable to provide blood sample
- Study Population 3: Control Women without Ovarian Cancer (n=30)
- 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
- Decompensated or end-stage heart failure (defined as ACC/AHA Stage C or Stage D heart failure)
- Venous thrombosis, myocardial infarction, or stroke within the last 8 weeks
- Personal history of ovarian cancer at any time
- History of bilateral salpingo-oophorectomy
- History of oophorectomy
Lab values
- 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)
- Poorly controlled diabetes mellitus (defined as a HbA1c \> 9.0%)
Other
- Currently pregnant or have been pregnant within the last 12 weeks
- Any blood product transfusion within the last 8 weeks
- Unable to provide blood sample
Who the study is looking for
- 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)
- 1\. Women aged 21 years or older
Criteria the registry did not label
- Study Populations 1 and 2: Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)
Age in the registry: 21 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.