The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer
NCT ID: NCT06665945
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
245 participants
OBSERVATIONAL
2025-04-15
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Women with a Recent Diagnosis of Ovarian Cancer (n=90)
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 Ovarian Mass (n=125)
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.
Control Women without Ovarian Cancer (n=30)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with any stage or type of ovarian cancer within the last 8 weeks
1\. Women aged 21 years or older
1. Women aged 21 years or older
2. Diagnosed with any type of ovarian mass within the last 8 weeks
Exclusion Criteria
2. Other diagnosis of any cancer within the last 6 months
3. Treatment for any cancer within the last 6 months
4. History of ovarian cancer at any time
5. Currently receiving chemotherapy for ovarian cancer
6. Has already undergone complete ovarian mass resection
7. Unable to provide blood sample
Study Population 2: Control Women without Ovarian Cancer (n=30)
1. Any active malignancy or diagnosis of cancer within the last 6 months
2. Treatment for any cancer within the last 6 months
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 Population 3: Women with a Recent Diagnosis of Ovarian Mass (n=125)
1. Any diagnosis of active malignancy
2. Any diagnosis of any cancer within the last 6 months
3. Treatment for any cancer within the last 6 months
4. History of ovarian cancer at any time
5. Currently receiving chemotherapy for ovarian cancer
6. Has already undergone complete ovarian mass resection
7. Unable to provide blood sample
21 Years
FEMALE
Yes
Sponsors
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University of Utah
OTHER
Responsible Party
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Principal Investigators
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Theresa Werner, MD
Role: PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute/ University of Utah
Locations
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Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HCI175150
Identifier Type: -
Identifier Source: org_study_id
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