Ovarian Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTPlatelet 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.
Sponsors
University of Utah
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early-Stage Ovarian Cancer Detection | 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. |
Countries
United States
Contacts
CONTACTSyrenna Lisonbee
PRINCIPAL_INVESTIGATORTheresa Werner, MD
Huntsman Cancer Institute/ University of Utah
Outcome results
None listed