Clinical trial NCT06665945: The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer
Official title: The SENTRY Study: Testing Whether Changes in Platelet RNA Enhance the Early Diagnosis of Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 245
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients in the Huntsman Cancer Hospital Clinics in Salt Lake City, Utah.

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.


Eligibility criteria: Study Population 1: Women with a Recent Diagnosis of Ovarian Cancer (n=90)

Inclusion Criteria:

1. Women aged 21 years or older
2. Diagnosed with any stage or type of ovarian cancer within the last 8 weeks

Exclusion Criteria:

1. Any other active malignancy
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)

Inclusion Criteria:

1. Women aged 21 years or older

Exclusion Criteria:

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)

Inclusion Criteria:

1. Women aged 21 years or older
2. Diagnosed with any type of ovarian mass within the last 8 weeks

Exclusion Criteria:

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

Primary outcomes:
measure: Early-Stage Ovarian Cancer Detection
timeFrame: Following informed consent (study visit 1, day 1).
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Theresa Werner, MD
role: PRINCIPAL_INVESTIGATOR
References: