Clinical trial · Observational
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
NCT06043661CI-TRIAL-00069810unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- BI-RADS score 1 or 2 or 3 (Cohort A)
- description
- Subjects with a standard risk of breast cancer aged 40 years and above at the time of mammography with the BI-RADS score 1 or 2 or 3
- label
- BI-RADS score 4 or 5 (Cohort B)
- description
- Subjects aged 40 years and above at the time of mammography with the BI-RADS score 4 or 5
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 2 years
- description
- The study evaluates the clinical sensitivity and specificity of the TriNetra Breast in Mammography-Negative (BIRAD 1/2/3) and Mammography-Positive (BIRAD 4/5) Cohorts
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDCrook T, Leonard R, Mokbel K, Thompson A, Michell M, Page R, Vaid A, Mehrotra R, Ranade A, Limaye S, Patil D, Akolkar D, Datta V, Fulmali P, Apurwa S, Schuster S, Srinivasan A, Datar R. Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells. Cancers (Basel). 2022 Jul 9;14(14):3341. doi: 10.3390/cancers14143341. PMID 35884402