Droplet-BC Screening Test for the Detection of Breast Cancer, the DROPLET-BC Study
- Conditions
- Breast Carcinoma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Droplet-BC TestOther: Electronic Health Record Review
- Registration Number
- NCT04671498
- Lead Sponsor
- Preferred Medicine, Inc
- Brief Summary
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
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1200
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-correlative (biospecimen collection) (Breast Cancer patients) Electronic Health Record Review Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. Ancillary-correlative (biospecimen collection) (Volunteer) Biospecimen Collection Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. Ancillary-correlative (biospecimen collection) (Volunteer) Electronic Health Record Review Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. Ancillary-correlative (biospecimen collection) (Breast Cancer patients) Droplet-BC Test Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. Ancillary-correlative (biospecimen collection) (Breast Cancer patients) Biospecimen Collection Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. Ancillary-correlative (biospecimen collection) (Volunteer) Droplet-BC Test Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.
- Primary Outcome Measures
Name Time Method Sensitivity of the Droplet-BC screening test for detecting breast cancer Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Specificity of the Droplet-BC screening test for detecting breast cancer Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
- Secondary Outcome Measures
Name Time Method 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 Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
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) Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Sensitivity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study) Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Specificity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study) Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Specificity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Sensitivity of the Droplet-BC screening test for the classification of early-stage breast cancer (BC) Up to study completion (estimated 18 months) 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.
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) Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Sensitivity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Sensitivity of the Droplet-BC test compared with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
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 Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Specificity of the Droplet-BC screening test for the classification of early-stage breast cancer Up to study completion (estimated 18 months) 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.
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 Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Sensitivity of the Droplet-BC test compared with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results Up to study completion (estimated 18 months) Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Trial Locations
- Locations (3)
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States