Early Detection of Breast Cancer
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ClinicalTrials.gov Identifier: NCT06043661 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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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.
Condition or disease |
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Breast Neoplasms |
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 700 subjects will be enrolled in one of the two non-overlapping cohorts in this study. Cohort A will enroll about 500 subjects with a standard risk of breast cancer who fulfill the enrollment criteria. Cohort B will enroll approximately 200 subjects with a mammogram result of BI-RADS 4 or 5.
The results of TriNetra™ -Breast will be compared with the results of mammography. The corresponding diagnostic biopsy pathology results obtained as the standard of care will be correlated with test results to confirm the performance estimates (when indicated). Mammography will be the reference standard of evaluation of breast screening status for cohort A. Histopathology report will be the reference standard to evaluate the malignant or non-malignant clinical status for cohort B. Availability of histopathological results is mandatory for the evaluation of cohort B.
Study Type : | Observational |
Estimated Enrollment : | 700 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | An Evaluation of a Circulating Tumor Cell-based Test (TriNetra™-Breast) for Breast Cancer Screening in Women Aged 40 and Above |
Actual Study Start Date : | February 9, 2023 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2025 |
Group/Cohort |
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BI-RADS score 1 or 2 or 3 (Cohort A)
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
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BI-RADS score 4 or 5 (Cohort B)
Subjects aged 40 years and above at the time of mammography with the BI-RADS score 4 or 5
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- 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. [ Time Frame: 2 years ]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
- The Positive Predictive Values (PPV) and Negative Predictive Values (NPV) [ Time Frame: 2 years ]The study evaluates the PPV and NPV of the TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods.
- Detection rates by TNM stage [ Time Frame: 2 years ]The study evaluates the detection rates (sensitivity in %) by TNM stage for the TriNetra Breast test, using surgical pathology evaluation as a reference.
- Clinical performance in dense breast findings on mammography [ Time Frame: 2 years ]The study evaluates the clinical sensitivity and specificity (in %) for the TriNetra Breast test in dense breast findings on mammography
- Sensitivity and specificity for ductal carcinoma in situ (DCIS) detection [ Time Frame: 2 years ]The study evaluates the clinical sensitivity and specificity (in %) for the TriNetra Breast test in ductal carcinoma in situ (DCIS) detection.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
The study population will consist of women aged 40 years and older. The target enrollment will be approximately 700 subjects, who will be divided into two non-overlapping cohorts.
All subjects enrolled in the study will undergo a blood draw for TriNetraTM Breast around the time of mammography. The blood draw will have to be performed no more than 60 days after the mammography and before the breast biopsy (Cohort B).
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043661
Contact: Ulka Vaishampayan, MBBS,MD | +17349367813 | vaishamu@umich.edu |
United States, Michigan | |
Rogel Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Ulka Vaishampayan, MD 734-936-7813 vaishamu@med.umich.edu | |
Sub-Investigator: Stephanie K Patterson, MD FACR FSBI | |
Sub-Investigator: Wahida Rahman (Tania), MD |
Responsible Party: | Datar Cancer Genetics Inc |
ClinicalTrials.gov Identifier: | NCT06043661 |
Other Study ID Numbers: |
HUM00217725 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Early Detection Mammography Circulating Tumor Cells Cancer Screening |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |