Status:
UNKNOWN
Droplet-BC Screening Test for the Detection of Breast Cancer, the DROPLET-BC Study
Lead Sponsor:
Preferred Medicine, Inc
Collaborating Sponsors:
M.D. Anderson Cancer Center
Conditions:
Breast Carcinoma
Eligibility:
All Genders
18+ years
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 sta...
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04671498
Start Date
November 3 2020
End Date
December 31 2022
Last Update
June 21 2022
Active Locations (3)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
3
M D Anderson Cancer Center
Houston, Texas, United States, 77030