Deepa Patel
Pronouns: she/her/hers
Research Mentor(s): Ulka Vaishampayan
Research Mentor School/College/Department: Internal Medicine, Hem/Oncology / Medicine
Program: UROP
Session: Session 6 (3:40pm – 4:30pm)
Authors: Ulka Vaishampayan, Neha Shah, Deepa Patel, Muntaha Rahman, Emma Zipperer
Abstract
Background: As breast cancer is prominent in women, mammography is recommended for women 40 and above; however, many are reluctant due to safety concerns. Hence, the development of a blood-based test, TriNetra™-Breast, may increase safety, be a more widely accepted method, and be helpful in screening asymptomatic women. A previous study in India with this device presented a 92.5% sensitivity for breast adenocarcinoma detection. It portrayed increased sensitivity to detect breast cancer and was not impacted by breast density. The TriNetra™ study is vital in demonstrating evidence of test performance and safety for the aforementioned U.S. population. Methods: Within this study, there are two cohorts: A & B, based on the Breast Imaging Reporting and Data System (BI-RADS). Cohort A consists of 500 subjects with a BI-RADS score of 1/2/3; Cohort B contains 200 subjects with a BI-RADS score of 4 or 5. Subjects will have blood drawn within 60 days after the mammography and before the breast biopsy (Cohort B). To analyze the specificity and sensitivity of TriNetra™-Breast, both histopathology and mammography will be used to confirm a diagnosis, if applicable. After the blood draw, subjects are followed up with every six months for a maximum of two years utilizing a phone call/email. Results: During subject recruitment, participants are recruited through phone calls or at various clinics before their mammography visit. Project results will not be available until participant enrollment is completed. After, the device’s sensitivity and specificity of breast cancer detection, (+/-) predictive values, the importance of findings, unexpected findings, research implications, and whether the lead time (2 years) for cancer detection is achieved will be assessed. Moreover, the device’s performance in dense breast findings on mammography will be determined. Conclusion: With confirmatory results, more subjects will be enrolled nationwide. After further confirmation, the FDA may clinically approve TriNetra™-Breast.
