Droplet-BC Screening Test for the Detection of Breast Cancer, the DROPLET-BC Study

PRIMARY OBJECTIVE:

I. To determine the sensitivity and specificity of the Droplet-BC screening test for distinguishing breast cancer (BC) patients from non-cancer volunteers, using reference data confirmed at sites.

SECONDARY OBJECTIVES:

I. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the classification of early-stage BC.

II. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for classifying patients into non-cancer volunteer (Breast Imaging-Reporting and Data System [BI-RADS] Categories 1 and 2) and BC patient subgroups.

III. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test to classify different subgroups between non-cancer volunteers (BI-RADS category 1) versus BC patients plus non-cancer volunteers (BI- RADS category 2).

IV. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study).

V. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the multi-classification among cancer stage.

VI. To compare the sensitivity of the Droplet-BC test with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results.

VII. To compare the sensitivity of the Droplet-BC test with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results.

VIII. To compare the sensitivity of the Droplet-BC test with MRI for detecting BC by extracting a subgroup of BC patients that have magnetic resonance imaging (MRI) results.

IX. To conduct all analyses described above with subgroups of participants matched as closely as possible for age, race/ethnicity, cancer history, current medication, family history of cancer, and/or breast cancer gene (BRCA) status.

EXPLORATORY OBJECTIVES:

I. To evaluate the sensitivity and specificity of the Droplet-BC test to detect cancer among different age groups.

II. To evaluate the sensitivity and specificity of the Droplet-BC test to detect cancer among individuals of differing ethnicities.

III. To compare expression levels of small ribonucleic acid (RNAs) among different age groups.

IV. To compare expression levels of small RNAs among individuals of differing ethnicities.

OUTLINE:

Participants undergo collection of blood sample for the Droplet-BC test. Breast cancer patients' medical records are also reviewed.