Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity

Childhood Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04036045
• Other study ID #: 18-137
• Status: Not yet recruiting
• Start date: January 2025
• Est. completion date: August 2030

Study information

• Verified date: February 2024
• Source: Connecticut Children's Medical Center
• Contact: Olga Salazar, MD
• Phone: 860-545-9400
• Email: Otoro[@]connecticutchildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: August 2030
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Childhood Cancer

Intervention

Other:
• Cardiac MRI
Patients will have a cardiac MRI at four time points during the study
• Echocardiogram
Patients will have an echocardiogram at four time points during the study
• 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.

Locations

Country	Name	City	State
United States	Olga Salazar	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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