Status:
WITHDRAWN
Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity
Lead Sponsor:
Connecticut Children's Medical Center
Collaborating Sponsors:
Nationwide Children's Hospital
Conditions:
Childhood Cancer
Eligibility:
All Genders
9-18 years
Brief Summary
Early microRNAs (miRs) and Cardiac Magnetic Resonance (CMR)-derived strain analysis and detection of genes contributing to Anthracycline-Induced Cardiotoxicity (AIC) sensitivity and resistance will id...
Detailed Description
Plan is to enroll 110 children and adults (≥9 years old) newly diagnosed at CCMC and Nationwide Children's Hospital (55 per institution) who will receive anthracyclines as part of their chemotherapy r...
Eligibility Criteria
Inclusion
- Age (≥ 9years old)
- Newly diagnosed with a malignancy that will receive ACs as part of their chemotherapy.
- Parental/caregiver consent and subject assent to enrollment.
Exclusion
- Subject has contraindications to CMR.\*
- Subject requiring sedation for CMR
- Subject too large to be safely accommodated by CMR
- Pregnancy tests are done routinely prior to chemotherapy, if test is positive the patient will be excluded
- Subject's serum creatinine above guidelines for adequate renal function. See table below:
- Age (years) Male Female 6-10 1.0 mg/dL 1.0 mg/dL 10-13 1.2 mg/dL 1.2 mg/dL 13-16 1.5 mg/dL 1.4 mg/dL \>16 1.7 mg/dL 1.4 mg/dL
Key Trial Info
Start Date :
November 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04036045
Start Date
November 12 2018
End Date
March 31 2025
Last Update
October 6 2025
Active Locations (1)
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1
Olga Salazar
Hartford, Connecticut, United States, 06106