Early Detection of Breast Cancer - Trial NCT06043661
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.
Study Focus
Observational
Sponsor & Location
Datar Cancer Genetics Inc
Timeline & Enrollment
N/A
Feb 09, 2023
Dec 01, 2025
Primary Outcome
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.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06043661
Non-Device Trial