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

Detection by Circulating RNA With Optimized Machine Learning Technology for Breast Cancer: DROPLET-BC Study

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

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Procedure: Droplet-BC Test

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Naoto T Ueno; Phone Number: 713-792-2817; Email: nueno@mdanderson.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University Feinberg School of Medicine
      • Contact: Seema A Khan, MD; Phone Number: 312-695-0990
      • Principal Investigator: Seema A Khan, MD
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
      • Contact: Shipra Gandhi, MD; Phone Number: 716-845-1285
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients and non-cancer volunteers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-correlative (biospecimen collection) (Breast Cancer patients); Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.	Procedure: Biospecimen Collection; Undergo collection of blood sample; Other: Electronic Health Record Review; Medical records are reviewed; Procedure: Droplet-BC Test; Undergo Droplet-BC Test
Ancillary-correlative (biospecimen collection) (Volunteer); Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.	Procedure: Biospecimen Collection; Undergo collection of blood sample; Other: Electronic Health Record Review; Medical records are reviewed; Procedure: Droplet-BC Test; Undergo Droplet-BC Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the Droplet-BC screening test for detecting breast cancer	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for detecting breast cancer	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the Droplet-BC screening test for the classification of early-stage breast cancer (BC)	Early-stage means breast ductal carcinoma in situ (DCIS) stage and stage I/II BC. Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of early-stage breast cancer	Early-stage means DCIS stage and stage I/II BC. Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (Breast Imaging Reporting and Data System [BI-RADS] categories 1 and 2) and BC patient subgroups	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (BI-RADS categories 1 and 2) and BC patient subgroups	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2)	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2)	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study)	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study)	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC test compared with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC test compared with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)
Sensitivity of Droplet-BC test compared with magnetic resonance imaging (MRI) for detecting BC by extracting a subgroup of BC patients that have MRI results	Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.	Up to study completion (estimated 18 months)

Collaborators and Investigators

• Sponsor: Preferred Medicine, Inc
• Collaborators: M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-0724 (OTHER: M D Anderson Cancer Center); NCI-2020-08583 (REGISTRY: CTRP (Clinical Trial Reporting Program)); MOD00009113 / IC-1243721 (OTHER: Roswell Park Comprehensive Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No