Early Detection of Breast Cancer

Description

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

Breast Neoplasms

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Study Overview

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Study Details

Study overview

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.

An Evaluation of a Circulating Tumor Cell-based Test (TriNetra™-Breast) for Breast Cancer Screening in Women Aged 40 and Above

Early Detection of Breast Cancer

Condition
Breast Neoplasms
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

Rogel Cancer Center, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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.
  • 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.

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Datar Cancer Genetics Inc,

Study Record Dates

2025-12