RECRUITING

Early Detection of Breast Cancer

Conditions

Breast Neoplasms Early Detection Mammography Circulating Tumor Cells Cancer Screening

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-02-09

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06043661

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Ulka Vaishampayan, MBBS,MD

CONTACT

+17349367813

vaishamu@umich.edu

Study Locations (Sites)

Rogel Cancer Center

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: Datar Cancer Genetics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-09

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-02-09

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Early Detection
Mammography
Circulating Tumor Cells
Cancer Screening

Additional Relevant MeSH Terms

Breast Neoplasms