NCT06043661

Early Detection of Breast Cancer

An Evaluation of a Circulating Tumor Cell-based Test (TriNetra™-Breast) for Breast Cancer Screening in Women Aged 40 and Above

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Datar Cancer Genetics Inc · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The TriNetra™ Breast test is intended for use as a breast cancer screening test that evaluates Circulating Tumor Cells (CTCs) associated with breast cancer. The TriNetra™Breast test should be a useful breast cancer screening option for asymptomatic women 40 years of age and older. This pivotal study is designed to provide evidence of test performance and to demonstrate its safety in the intended use population in the USA.

Detailed description

This prospective, case-cohort study evaluates the sensitivity and specificity of the TriNetra™-Breast test for breast cancer (adenocarcinoma) screening in women aged 40 years and older. Approximately 700 subjects will be enrolled in one of the two non-overlapping cohorts in this study. Cohort A will enroll about 500 subjects with a standard risk of breast cancer who fulfill the enrollment criteria. Cohort B will enroll approximately 200 subjects with a mammogram result of BI-RADS 4 or 5. The results of TriNetra™ -Breast will be compared with the results of mammography. The corresponding diagnostic biopsy pathology results obtained as the standard of care will be correlated with test results to confirm the performance estimates (when indicated). Mammography will be the reference standard of evaluation of breast screening status for cohort A. Histopathology report will be the reference standard to evaluate the malignant or non-malignant clinical status for cohort B. Availability of histopathological results is mandatory for the evaluation of cohort B.

Conditions

• Breast Neoplasms

Timeline

• Start date: 2023-02-09
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: United States