Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity

Sponsor

Connecticut Children's Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04036045

Collaborator

Nationwide Children's Hospital (Other)

110

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer	Other: Cardiac MRI Other: Echocardiogram Other: Blood Draw

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

110 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2028

Anticipated Study Completion Date :

Aug 1, 2030

Outcome Measures

Primary Outcome Measures

CMR [From Baseline to one year after anthracycline therapy]
1. Increased myocardial T2 relaxation time in the myocardium compared to baseline as measured by T2 mapping technique

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Olga Salazar	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

Connecticut Children's Medical Center
Nationwide Children's Hospital

Investigators

Principal Investigator: Olga Salazar, MD, Connecticut Children's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Olga Salazar, Principal Investigator, Connecticut Children's Medical Center

ClinicalTrials.gov Identifier:

NCT04036045

Other Study ID Numbers:

18-137

First Posted:

Jul 29, 2019

Last Update Posted:

Jan 13, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Olga Salazar, Principal Investigator, Connecticut Children's Medical Center

Anthracycline induced cardiotoxicity

Additional relevant MeSH terms:

Cardiotoxicity

Study Results

No Results Posted as of Jan 13, 2022