An observational study in Breast Carcinoma, sponsored by Preferred Medicine, Inc. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Preferred Medicine, Inc · Observational
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
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Preferred Medicine, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Breast cancer patients and non-cancer volunteers.
Exclusion Criteria:
Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.
Procedure: Biospecimen Collection · Procedure: Droplet-BC Test · Other: Electronic Health Record Review
Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.
Procedure: Biospecimen Collection · Procedure: Droplet-BC Test · Other: Electronic Health Record Review
Undergo collection of blood sample
Undergo Droplet-BC Test
Medical records are reviewed
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.
Time frame: 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.
Time frame: Up to study completion (estimated 18 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to study completion (estimated 18 months)
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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