Early Detection of Breast Cancer

NCT06043661 | Unknown DMC

• 1 other identifier: HUM00217725
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Early Detection; Mammography; Circulating Tumor Cells; Cancer Screening

Outcome Measures

Primary Outcomes (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.

  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

  2 years

Secondary Outcomes (4)

• The Positive Predictive Values (PPV) and Negative Predictive Values (NPV)

  2 years

• Detection rates by TNM stage

  2 years

• Clinical performance in dense breast findings on mammography

  2 years

• Sensitivity and specificity for ductal carcinoma in situ (DCIS) detection

  2 years

Study Arms (2)

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

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Datar Cancer Genetics Inc: lead

Study Sites (1)

Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35884402 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ulka Vaishampayan, MBBS,MD

CONTACT

+17349367813; vaishamu@umich.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: February 9, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)