Clinical trial · Observational
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
NCT04671498CI-TRIAL-00059174unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Droplet-BC Test | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Ancillary-correlative (biospecimen collection) (Breast Cancer patients)
- description
- Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Droplet-BC Test
- Other: Electronic Health Record Review
- label
- Ancillary-correlative (biospecimen collection) (Volunteer)
- description
- Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Droplet-BC Test
- Other: Electronic Health Record Review
Primary outcomes (2)
- measure
- Sensitivity of the Droplet-BC screening test for detecting breast cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.