Status:
UNKNOWN
Early Detection of Breast Cancer
Lead Sponsor:
Datar Cancer Genetics Inc
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
40+ years
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...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- Subjects who are receiving any investigational agent.
- Pregnant women are excluded from this study
- Breastfeeding women are excluded from this study
- Blood transfusion within 30 days prior to screening,
- Subject has any condition that in the opinion of the investigator should preclude participation in the study.
Exclusion
Key Trial Info
Start Date :
February 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06043661
Start Date
February 9 2023
End Date
December 1 2025
Last Update
September 21 2023
Active Locations (1)
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1
Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109