Early Detection of Breast Cancer
Status unconfirmed
Conditions studied: Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT06043661
- Run by
- Datar Cancer Genetics Inc
- People needed
- 700
- Starts
- 2023-02-09
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2023-09-21
Who can join
Age: 40 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
- Agreeable to share any future biopsy or imaging data for a maximum of 2 years from study blood draw.
- B). For Cohort B (BI-RADS 4 and 5) (200 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
- Current mammography indicating BI-RADS 4a,4b, 4c, or 5
- Capable of providing adequate health history
- No co-morbidity which could impair study participation or sample collection
- Blood draw within sixty (60) days of mammography and prior to biopsy of the breast
- Yet to undergo tissue diagnostic procedure for breast lesion such as fine needle, core, or excisional biopsy
- A redacted/deidentified mammography report and redacted/de-identified pathology report will be available and provided
- Willingness to accept follow-up contact every 6 months for up to 2 years.
- Agreeable to share any future repeat biopsy or imaging data for a maximum of 2 years from study blood draw.
- C). Exclusion Criteria
- Prior diagnosis of (any) cancer
Where it is running
- Rogel Cancer Center — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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