Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity

NCT ID: NCT04036045

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2025-03-31

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 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Cardiac MRI

Patients will have a cardiac MRI at four time points during the study

Intervention Type: OTHER

Echocardiogram

Patients will have an echocardiogram at four time points during the study

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

cMRI; Echo

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Salazar, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

Olga Salazar

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

18-137

Identifier Type: -

Identifier Source: org_study_id