The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Platelet RNA expression.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 21 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test 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.
Primary outcome measures
- Early-Stage Ovarian Cancer Detection [Time frame: Following informed consent (study visit 1, day 1).]
Eligibility 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
1\. 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Huntsman Cancer Institute — Salt Lake City
Identifiers
NCT: NCT06665945 · HCI175150