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Introduction The Standard of Care for early detection of breast cancer in asymptomatic women is screening mammography, which has limitations such as radiation exposure and lower sensitivity to detect cancer in women with high breast density or invasive carcinomas. TriNetra™-Breast is a blood test for the detection of breast cancer associated circulating tumor cells in blood. Previously, this test has been used in a study for breast cancer detection in India, where it has shown a sensitivity of 92.5%. It has since been granted the United States Food and Drug Administration (USFDA) Breakthrough Device Designation, attesting its potential to provide for improved detection of breast cancer. This prospective, observational, case-cohort study will confirm the clinical performance characteristics of the technology in the US population. Patients and Methods The primary endpoint of this study will be to determine the sensitivity and specificity of the test for breast cancer screening, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods. Women ≥40 years, with no prior diagnosis of any cancer and undergoing screening mammography for breast cancer will be eligible for participation in this study. 700 women, representing the diverse ethnic US population, will be enrolled. Cohort A will have 500 women with BI-RADS score of 1, 2, or 3. Among these 500 participants, the age categories of 40-49 years, 50-74 years and >74 years will have 100, 300 and 100 women respectively. Cohort B will have 100 women with suspicion of DCIS (without a suspicion of simultaneous invasive carcinoma) and 50 women each with BI-RADS score of 4 or 5. These study population numbers will ensure optimal representation of in-situ carcinoma, malignant and benign cases. Blood samples will be collected from the enrolled women for TriNetra™-Breast, within sixty (60) days of the screening mammogram. If biopsy is indicated, sample collection will be required prior to the procedure. The lab investigators will be blinded to the clinical information of all participants, including mammography and histopathology results, while the participants and clinical investigators will be blinded to the TriNetra™-Breast test results. The results of TriNetra™-Breast will be compared with the results of mammography and/or histopathology for performance estimation of the test. Study participants will be followed for clinical outcomes for maximum duration of 2 years. Citation Format: Ulka Vaishampayan, Darshana Patil, Wahida Rahman, Stephanie Patterson, Emilija Mitrikeska, Joe Dib. Clinical validation of “TriNetra™-Breast” test for breast cancer screening in a prospective, observational, case-cohort study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-18-02. |
