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

NCT06665945 | Recruiting

• 1 other identifier: HCI175150
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Early-Stage Ovarian Cancer Detection

  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).

Study Arms (2)

Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)

Diagnostic Test: Platelet RNA expression

Control Women without Ovarian Cancer (n=30)

Diagnostic Test: Platelet RNA expression

Interventions

Platelet RNA expression DIAGNOSTIC_TEST

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.

Control Women without Ovarian Cancer (n=30); Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)
• \. Women aged 21 years or older
• 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%)

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study will obtain platelet RNA samples from whole blood.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Theresa Werner, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syrenna Lisonbee

CONTACT

801-585-0161; Syrenna.Lisonbee@hci.utah.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 30, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)