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

Preferred Medicine

Status

Enrolling

Conditions

Breast Carcinoma

Treatments

Other: Electronic Health Record Review

Procedure: Droplet-BC Test

Procedure: Biospecimen Collection

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04671498

MOD00009113 / IC-1243721 (Other Identifier)

NCI-2020-08583 (Registry Identifier)

2020-0724 (Other Identifier)

Details and patient eligibility

About

This study investigates if a new type of test called Droplet-BC screening test can classify breast cancer patients from non-cancer volunteers by circulating small-noncoding RNA in the blood with a statistical validity. This study also investigates if this test can classify the subgroup of breast cancer patients with a variety of conditions. Information from this study may provide a new method of breast cancer screening/diagnosis

Full description

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.

Enrollment

1,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

BREAST CANCER PATIENTS: Newly diagnosed with breast cancer
BREAST CANCER PATIENTS: Not received cancer treatment for newly diagnosed with breast cancer
BREAST CANCER PATIENTS: Able to comprehend, sign, and date the written informed consent document to participate in the study
BREAST CANCER PATIENTS: Able and willing to provide a one-time blood sample
BREAST CANCER PATIENTS: Age >= 18 years old
NON-CANCER VOLUNTEERS: Have undergone a screening mammogram
NON-CANCER VOLUNTEERS: Not currently taking any drugs for cancer treatment or any cancer prevention medication
NON-CANCER VOLUNTEERS: Able to comprehend, sign, and date the written informed consent document to participate in this study
NON-CANCER VOLUNTEERS: Able and willing to provide blood samples according to provided written instructions
NON-CANCER VOLUNTEERS: Seen by a provider (physician or advanced practice nurse [APN]) in the Cancer Prevention clinic at MD Anderson Cancer Center or other participating sites
NON-CANCER VOLUNTEERS: Age >= 18 years old

Exclusion criteria

BREAST CANCER PATIENTS: Known current pregnancy
BREAST CANCER PATIENTS: History of breast cancer treatment in the past
BREAST CANCER PATIENTS: Participation in any interventional clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
BREAST CANCER PATIENTS: Any condition that, in the opinion of the investigator, should preclude participation in the study
NON-CANCER VOLUNTEERS: Known current pregnancy
NON-CANCER VOLUNTEERS: History of breast cancer (breast ductal carcinoma in situ [DCIS] and invasive)
NON-CANCER VOLUNTEERS: History of any cancer except non-melanoma skin cancer and cervical dysplasia
NON-CANCER VOLUNTEERS: Participation in any interventional clinical study within the previous 30 days in which experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
NON-CANCER VOLUNTEERS: Any condition that in the opinion of the investigator, should preclude participation in the study