NCT04036045

Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity

Integrated Basis and Translational Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Connecticut Children's Medical Center · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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 identify pediatric cancer patients most and least likely to develop AIC.

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 regimen. The duration of study participation will be approximately a year. Patients will have a total of four study visits: Baseline 1 week after patient's anthracycline cumulative dose hits between 60 and 100 mg/m2 After the patient has completed maximal therapy One year after completion of anthracycline treatments Study tasks for all four visits will be: Collection of clinical data Blood draw for micro RNA and Biomarkers Cardiac MRI Echocardiogram One time blood draw for genetics

Conditions

• Childhood Cancer

Interventions

Type	Name	Description
OTHER	Cardiac MRI	Patients will have a cardiac MRI at four time points during the study
OTHER	Echocardiogram	Patients will have an echocardiogram at four time points during the study
OTHER	Blood Draw	Patients will have blood drawn at four time points to analyze micro RNAs and Biomarkers before, during and after anthracycline treatment. Patients will also have one blood draw for future genetic sequencing.

Timeline

• Start date: 2018-11-12
• Primary completion: 2024-12-01
• Completion: 2025-03-31
• First posted: 2019-07-29
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States