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

University of Utah · NCT06665945

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21+ · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
245
US sites recruiting
1
Study start
April 15, 2025
Record last updated
April 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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 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.

Being studied: Platelet RNA expression

Conditions: Ovarian Cancer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Study Populations 1 and 2: Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)

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

  • 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

Recruiting US locations

  • Huntsman Cancer Institute

    Salt Lake City, UT 84112

    Site contact: Kim Norman, MPH, CPH · 801-581-5895 · Kim.Norman@hci.utah.edu

Study contacts (from the official record)

  • Syrenna Lisonbee · 801-585-0161 · Syrenna.Lisonbee@hci.utah.edu
All healthy volunteers studies in Utah →
The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance… (NCT06665945) | Bored Studies