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NCT07872644
Safety in Ovarian Cancer for Average-Risk Women - Analysis
Conditions: Ovarian Cancer
Sex: Female
Ages: 50 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 1750
Sponsor: Mercy BioAnalytics, Inc.
Location: Mercy BioAnalytics, Inc. Waltham Massachusetts
Summary
This study is designed to evaluate the safety, specificity, and downstream diagnostic burden of the Evident™ Ovarian Cancer Screening Test in average-risk postmenopausal women. Participants will provide a blood sample for screening and will be followed for approximately 12 months to assess test safety, specificity, downstream diagnostic procedures, and ovarian cancer outcomes.
Eligibility Criteria
Inclusion Criteria:
* Postmenopausal women with one or both ovaries
* Age 50 years or more
* No personal history of ovarian cancer
* No hereditary cancer syndrome of genetic risk factors associated with ovarian cancer
* Willingness to allow medical record review
* Willingness to have blood drawn
* Ability to provide informed consent
Exclusion Criteria:
* Removal of both ovaries for any reason
* Known genetic risk factors associated with ovarian cancer or hereditary cancer syndrome
* Pregnant or breastfeeding
* Currently under clinical surveillance due to a known or suspected elevated risk of developing ovarian cancer
* Women who are symptomatic and being evaluated for ovarian cancer
* Current untreated malignancy (other than non-melanoma skin cancer)
* Currently receiving adjuvant chemotherapy or radiation therapy for cancer. Patients who are being treated may enroll 3 months after completion of last treatment.
* Anticoagulant use (self-reported)
* Known conditions posing unacceptable phlebotomy risk (self-reported)
* Unwilling to provide the name of primary care physician or provider
* Unwilling to sign informed consent and/or medical records release form.
Source: ClinicalTrials.gov (NCT07872644). StuddyBuddy aggregates publicly available trial information.