Droplet-BC Screening Test for the Detection of Breast Cancer, the DROPLET-BC Study
NCT ID: NCT04671498
Last Updated: 2022-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1200 participants
OBSERVATIONAL
2020-11-03
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood sample
Droplet-BC Test
Undergo Droplet-BC Test
Electronic Health Record Review
Medical records are reviewed
Ancillary-correlative (biospecimen collection) (Volunteer)
Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.
Biospecimen Collection
Undergo collection of blood sample
Droplet-BC Test
Undergo Droplet-BC Test
Electronic Health Record Review
Medical records are reviewed
Interventions
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Biospecimen Collection
Undergo collection of blood sample
Droplet-BC Test
Undergo Droplet-BC Test
Electronic Health Record Review
Medical records are reviewed
Eligibility Criteria
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Inclusion Criteria
* 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: 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
18 Years
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Preferred Medicine, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Naoto T Ueno
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Seema A Khan, MD
Role: primary
Shipra Gandhi, MD
Role: primary
Naoto T. Ueno
Role: primary
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2020-08583
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0724
Identifier Type: OTHER
Identifier Source: secondary_id
MOD00009113 / IC-1243721
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0724
Identifier Type: -
Identifier Source: org_study_id
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