NCT06665945 · University of Utah
The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer
(SENTRY)
What this study is about
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 reviewing past data data, the investigators have developed an approach that appears to accurately classify ovarian cancer with relatively high sensitivity and specificity.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Platelet RNA expression
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.
Primary outcome measures
Early-Stage Ovarian Cancer Detection
Time frame: Following informed consent (study visit 1, day 1).
The goal is to determine if changes in platelet RNA expression accurately diagnoses ovarian cancer. This outcome will report the number of true positive, true negative, false positive, and false negative results from this assay.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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: 1\. 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
Where
- Salt Lake City, Utah
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations