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NCT03505164 · ClinicalTrials.gov registry record
The Role of suPAR Biomarker in Blood Samples of Breast Cancer Patients During and Post Doxorubicin Chemotherapy: Causative vs. Predictor
A clinical trial, sponsored by Rush University Medical Center.
- Completed
- Registry status
- 42
- Enrollment target
NCT03505164: Completed study, sponsored by Rush University Medical Center.
NCT03505164 is a clinical trial that has completed, run by Rush University Medical Center. The registered enrollment target is 42 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03505164 has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
Study Summary
This study looks to find a causative or predictive aspect of the suPAR biomarker for heart failure in breast cancer patients receiving Doxorubicin drug chemo regimen. suPAR is a circulating protein which can be found in blood and/or urine and is associated with both kidney and heart disease. * Hypothesis 1: Higher suPAR at baseline will predispose to Doxorubicin-induced cardiomyopathy or heart failure, observed by histology (under the microscope and other lab techniques) in mouse models, and tested using heart ultrasound techniques in humans. * Hypothesis 2: suPAR is a marker of Doxorubicin-induced cardiomyopathy or heart failure after exposure to Doxorubicin, observed by histology (under the microscope and other lab techniques) in mouse models, and tested in humans. The study will look at suPAR's association with three other biomarkers called troponin, B-Type Natriuretic Peptide (BNP) and C- Reactive Protein (CRP) that are also associated with heart disease. In this study, the patient will have blood drawn as a routine part of the cancer treatment. That is prior to starting the cancer therapy, then after the first 2 and last 2 doxorubicin cycles (4 cycles altogether); as well as at 3, 6, \& 12 months after doxorubicin treatment. (6 Visits in total) The patient will also have an echocardiogram (echo, heart ultrasound) at each of these time points. The first of the six study echos is considered part of the routine care.
Primary Outcome
A blood draw will be done at baseline for all participants. The blood samples will be processed by Centrifugation, to separate the plasma, and the suPAR level measured using ELISA technique, to stratify the participants that have a higher or normal baseline. Although there is no current consensus regarding normal suPAR blood level, a level of 3000 pg/mL is considered a high level. Higher baseline blood level of suPAR, will predispose patients with breast cancer undergoing chemo regimen contain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-01-17 |
| Est. Completion | 2020-07-06 |
What the finished NCT03505164 record still lists
NCT03505164 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03505164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03505164 about?
NCT03505164 is a clinical study titled "The Role of suPAR Biomarker in Blood Samples of Breast Cancer Patients During and Post Doxorubicin Chemotherapy: Causative vs. Predictor". This study looks to find a causative or predictive aspect of the suPAR biomarker for heart failure in breast cancer patients receiving Doxorubicin drug chemo regimen. suPAR is a circulating protein which can be found in blood and/or urine and is associated with both kidney and heart disease. * Hyp...
What is the current status of trial NCT03505164?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2017-01-17. Estimated completion is 2020-07-06.
Who is sponsoring clinical trial NCT03505164?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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