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NCT01771549 · ClinicalTrials.gov registry record
Kinetics of Troponin and BNP in Breast Cancer Chemotherapy With Adriamycin and Trastuzumab
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 26
- Enrollment target
NCT01771549: Completed study, sponsored by Mayo Clinic.
NCT01771549 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01771549 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
Study Summary
This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are frequently elevated after experimental chemotherapy in animal models. Their behavior in humans has been inconsistent, with occasional elevations seen, usually within 30 days of therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced. A majority of patients greater than age 50 have elevations above the detection limit, compared to only 1-3% with conventional troponin assays, and over 90% of diabetics have elevations above the detection limit. Moreover, augmented release of high sensitivity troponin is detected after exercise or rapid atrial pacing of durations of 10-15 minutes in patients with and without coronary artery disease. This improved sensitivity suggests the potential for detection and monitoring of cardiac damage after cancer chemotherapy. We hypothesized that this new generation of troponin assay would be associated with kinetic behavior suggesting ongoing cardiac damage with anthracycline therapy, and possibly also with trastuzumab.
Primary Outcome
Concentration-time plots from pre-treatment through days 1,2,3,7,and pre-cycle two
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-06-26 |
What the finished NCT01771549 record still lists
NCT01771549 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01771549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01771549 about?
NCT01771549 is a clinical study titled "Kinetics of Troponin and BNP in Breast Cancer Chemotherapy With Adriamycin and Trastuzumab". This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first t...
What is the current status of trial NCT01771549?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2013-01. Estimated completion is 2017-06-26.
Who is sponsoring clinical trial NCT01771549?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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