Early Detection of Breast Cancer

• ClinicalTrials.gov Identifier: NCT06043661
• Recruitment Status: Recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Datar Cancer Genetics Inc
• Information provided by (Responsible Party): Datar Cancer Genetics Inc

Study Description

Brief Summary:

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
Breast Neoplasms

Detailed Description:

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 Design

• 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

Groups and Cohorts

Group/Cohort
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
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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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
4. 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.

Eligibility Criteria

• 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

Study Population

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).

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.

Contacts and Locations

Contacts

Contact: Ulka Vaishampayan, MBBS,MD; +17349367813; vaishamu@umich.edu

Locations

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

Sponsors and Collaborators

Datar Cancer Genetics Inc

More Information

Publications:

Crook 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.

• Responsible Party: Datar Cancer Genetics Inc
• ClinicalTrials.gov Identifier: NCT06043661
• Other Study ID Numbers: HUM00217725
• First Posted: September 21, 2023
• 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

Keywords provided by Datar Cancer Genetics Inc:

Early Detection; Mammography; Circulating Tumor Cells; Cancer Screening

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases