An Evaluation of a Circulating Tumor Cell-based Test (TriNetra™-Breast) for Breast Cancer Screening in Women Aged 40 and Above
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Datar Cancer Genetics Inc
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- The primary endpoint of this study is the sensitivity and specificity of TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A). For Cohort A (500 subjects are targeted to enroll)
- •No prior diagnosis of (any) cancer
- •Women aged 40 years and above at the time of mammography
- •Provision of signed informed consent
- •Capable of providing adequate health history
- •No co-morbidity which could impair study participation or sample collection
- •Blood draw within sixty (60) days of performance of screening mammography
- •A redacted/deidentified mammography report will be available and provided
- •If any prior mammography was performed, the BI-RADS score should be 1 or 2 or 3
- •Willingness to accept follow-up contact every 6 months for up to 2 years.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The primary endpoint of this study is the sensitivity and specificity of TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods.
Time Frame: 2 years
The study evaluates the clinical sensitivity and specificity of the TriNetra Breast in Mammography-Negative (BIRAD 1/2/3) and Mammography-Positive (BIRAD 4/5) Cohorts
Secondary Outcomes
- Sensitivity and specificity for ductal carcinoma in situ (DCIS) detection(2 years)
- The Positive Predictive Values (PPV) and Negative Predictive Values (NPV)(2 years)
- Detection rates by TNM stage(2 years)
- Clinical performance in dense breast findings on mammography(2 years)