Testing a new method for early detection of breast cancer
An Evaluation of a Circulating Tumor Cell-based Test (TriNetra™-Breast) for Breast Cancer Screening in Women Aged 40 and Above
This study is testing a new breast cancer screening method using a blood test to see if it works better than regular mammograms for women aged 40 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Datar Cancer Genetics Inc Industry-sponsored |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06043661 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the TriNetra™ Breast test, which assesses Circulating Tumor Cells (CTCs) for breast cancer screening in women aged 40 and older. It involves two cohorts: one with standard risk women and another with women who have suspicious mammogram results. The study aims to compare the performance of the TriNetra™ test against traditional mammography and confirm its safety and effectiveness. Approximately 700 participants will be enrolled to provide robust data on the test's sensitivity and specificity.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 years and older with no prior cancer diagnosis.
Not a fit: Patients with a prior diagnosis of cancer or those who do not meet the age requirement may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could provide a more accurate and less invasive method for early breast cancer detection.
How similar studies have performed: Other studies have shown promise in using circulating tumor cells for cancer detection, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A). For Cohort A (500 subjects are targeted to enroll) 1. No prior diagnosis of (any) cancer 2. Women aged 40 years and above at the time of mammography 3. Provision of signed informed consent 4. Capable of providing adequate health history 5. No co-morbidity which could impair study participation or sample collection 6. Blood draw within sixty (60) days of performance of screening mammography 7. A redacted/deidentified mammography report will be available and provided 8. If any prior mammography was performed, the BI-RADS score should be 1 or 2 or 3 9. Willingness to accept follow-up contact every 6 months for up to 2 years. 10. 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) 1. No prior diagnosis of (any) cancer 2. Women aged 40 years and above at the time of mammography 3. Provision of signed informed consent 4. Current mammography indicating BI-RADS 4a,4b, 4c, or 5 5. Capable of providing adequate health history 6. No co-morbidity which could impair study participation or sample collection 7. Blood draw within sixty (60) days of mammography and prior to biopsy of the breast 8. Yet to undergo tissue diagnostic procedure for breast lesion such as fine needle, core, or excisional biopsy 9. A redacted/deidentified mammography report and redacted/de-identified pathology report will be available and provided 10. Willingness to accept follow-up contact every 6 months for up to 2 years. 11. Agreeable to share any future repeat biopsy or imaging data for a maximum of 2 years from study blood draw. C). Exclusion Criteria 1. Prior diagnosis of (any) cancer 2. Subjects who are receiving any investigational agent. 3. Pregnant women are excluded from this study 4. Breastfeeding women are excluded from this study 5. Blood transfusion within 30 days prior to screening, 6. Subject has any condition that in the opinion of the investigator should preclude participation in the study.
Where this trial is running
Ann Arbor, Michigan
- Rogel Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Ulka Vaishampayan, MBBS,MD
- Email: vaishamu@umich.edu
- Phone: +17349367813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.