Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity

NCT04036045 | Withdrawn

• 1 other identifier: 18-137
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer

Keywords

Anthracycline induced cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• CMR

  1\. Increased myocardial T2 relaxation time in the myocardium compared to baseline as measured by T2 mapping technique

  From Baseline to one year after anthracycline therapy

Interventions

Cardiac MRI OTHER

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

Also known as: cMRI

Echocardiogram OTHER

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

Also known as: Echo

Blood Draw OTHER

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.

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are \> or equal to 9 years of age who are newly diagnosed with cancer who will receive anthracycline (s) as part of the their treatment regimen.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Olga Salazar

Hartford, Connecticut, 06106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

pending

MeSH Terms

Conditions

Neoplasms

Interventions

Caves; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Olga Salazar, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: November 12, 2018
• Primary Completion: December 1, 2024
• Study Completion: March 31, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

US (1)