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

April 3, 2026 updated by: University of Utah
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Principal Investigator:
          • Theresa Werner, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be patients in the Huntsman Cancer Hospital Clinics in Salt Lake City, Utah.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Women without Ovarian Cancer (n=30)
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.
Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Following informed consent (study visit 1, day 1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Theresa Werner, MD, Huntsman Cancer Institute/ University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCI175150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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