Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer
Trial Status: active
This study evaluates whether changes in platelets can be used to accurately identify women with ovarian cancer.
Inclusion Criteria
- Study Population 1: Women with a Recent Diagnosis of Ovarian Cancer: * Women aged 21 years or older * Diagnosed with any stage or type of ovarian cancer within the last 8 weeks Study Population 2: Control Women without Ovarian Cancer: * Women aged 21 years or older Study Population 3: Women with a Recent Diagnosis of Ovarian Mass: * Women aged 21 years or older * Diagnosed with any type of ovarian mass within the last 8 weeks
Exclusion Criteria
- Study Population 1: Women with a Recent Diagnosis of Ovarian Cancer: * Any other active malignancy * Other diagnosis of any cancer within the last 6 months * Treatment for any cancer within the last 6 months * History of ovarian cancer at any time * Currently receiving chemotherapy for ovarian cancer * Has already undergone complete ovarian mass resection * Unable to provide blood sample Study Population 2: Control Women without Ovarian Cancer: * Any active malignancy or diagnosis of cancer within the last 6 months * Treatment for any cancer within the last 6 months * 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 Study Population 3: Women with a Recent Diagnosis of Ovarian Mass: * Any diagnosis of active malignancy * Any diagnosis of any cancer within the last 6 months * Treatment for any cancer within the last 6 months * History of ovarian cancer at any time * Currently receiving chemotherapy for ovarian cancer * Has already undergone complete ovarian mass resection * Unable to provide blood sample
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06665945.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Contact: Theresa Louise Werner
Email: theresa.werner@hci.utah.edu
PRIMARY OBJECTIVE:
I. To test whether combining a unique analytical approach with changes in platelet RNA expression accurately diagnoses ovarian cancer.
OUTLINE: This is an observational study.
Participants undergo blood sample collection and have their medical records reviewed on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorTheresa Louise Werner
- Primary IDHCI175150
- Secondary IDsNCI-2024-08522
- ClinicalTrials.gov IDNCT06665945