Safety in Ovarian Cancer for Average-Risk Women - Analysis (SOARA)

Mercy BioAnalytics, Inc.

Status: Not yet enrolling

Conditions: Ovarian Cancer

Treatments: Diagnostic Test: Blood-Based Ovarian Cancer Screening Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT07872644

CS-3

Details and patient eligibility

About

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.

Full description

This is a prospective, decentralized clinical study of the Evident Ovarian Cancer Screening Test in average-risk postmenopausal women aged 50 years and older. Between 1,000 and up to 1,750 participants will be enrolled. The study is intended to characterize the safety profile of the screening strategy, estimate test specificity, and evaluate the burden of downstream diagnostic procedures associated with positive screening results.

Eligible participants will complete informed consent procedures and undergo blood collection through a mobile phlebotomy service. Blood specimens will be analyzed using the Evident Ovarian Cancer Screening Test. Participants with negative screening results will not be required to undergo any further study procedures. Participants with positive screening results will be required to undergo transvaginal ultrasound (TVUS) and may elect to undergo additional Evident testing during follow-up. Clinical management decisions will remain under the direction of the participant's treating healthcare provider.

Clinical outcomes will be assessed through participant surveys, medical record review when available, and review of relevant imaging and diagnostic findings. Outcomes of interest include adverse events associated with the screening pathway, invasive diagnostic procedures, ovarian cancer diagnoses, and participant-reported psychological burden associated with positive screening results.

The primary objectives of the study are to evaluate the safety of the screening strategy, estimate the specificity of the Evident Ovarian Cancer Screening Test, and characterize the downstream procedural burden associated with positive test results in the intended-use population.

Enrollment: 1,750 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,750 participants in 1 patient group

Average-Risk

Experimental group

Description:

Postmenopausal women aged 50 years or older with no known current ovarian cancer, other active malignancy, or established ovarian cancer risk factors. The study will aim to enroll a diverse population generally representative of the US population with respect to race and ethnicity.

Treatment:

Diagnostic Test: Blood-Based Ovarian Cancer Screening Test