Early Detection of Breast Cancer
- Disease/Condition
- Breast Neoplasms
- Study type
- Observational
- Primary sponsor
- Datar Cancer Genetics Inc
- Location
- Ann Arbor, United States of America
- Phase
- N/A
- Start date
- Feb 09, 2023
- End date
- Dec 01, 2025
- Enrollment
- 700 participants
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.
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06043661
- Type
- Non-Device Trial
Access comprehensive clinical trial information for NCT06043661 through Pure Global AI's free database. This phase not specified trial is sponsored by Datar Cancer Genetics Inc and is currently Recruiting. The study focuses on Breast Neoplasms. Target enrollment is 700 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.