Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy

NCT01671696 | Completed

• 1 other identifier: 10-096 CCMC
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The main hypothesis being tested is that magnetic resonance imaging and serologic biomarkers of apoptosis and extracellular matrix remodeling will precede echocardiographic indices of systolic and diastolic function among childhood cancer survivors treated with anthracyclines thus allowing evaluation of new therapies to prevent and manage heart failure in these patients.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• To see if a CMRI is better at detecting occult asymptomatic cardiotoxicity

  Changes in T1 mapping-derived relaxation time and left ventricular myocardial peak circumferential and longitudinal strain magnitude and segmental circumferential strain magnitude are present in asymptomatic post-chemotherapy pediatric patients who have normal standard CMRI parameters. Circumferential strain analysis and measurement of the T1 myocardial relaxation time by CMRI may accurately identify occult cardiovascular dysfunction in patients exposed to high dose anthracyclines.

  2 year

Secondary Outcomes (1)

• To quantitate serological markers of diffuse myocardial fibrosis and apoptosis

  1 year

Other Outcomes (1)

• To conduct phenotype analysis of DNA/microRNA of patients exposed to anthracycline

  1 year

Interventions

Cardiac MRI OTHER

Cardiac MRI

Eligibility Criteria

• Age: 9 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Survivors of childhood cancer who were treated with anthracyclines and are greater than 2 years from their last cycle of chemotherapy

You may qualify if:

• Childhood cancer survivors from the late effect clinic who had received ≥240 mg/m2 anthracyclines, been in complete remission and off chemotherapy for a minimum of 2 years.
• Age \> 9 years of age\*
• Parental/caregiver consent and subject assent to enrollment
• Enrolled in part A of the study, which took place from October 2011 to July 2013.
• Childhood cancer survivors from the late effect clinic who had received \< 300 mg/m2 anthracyclines, been in complete remission and off chemotherapy for a minimum of 1 year
• Age ≥ 9 years of age\*
• Parental/caregiver consent and subject assent to enrollment
• \* Age \> 9 years of age was chosen to avoid the need for general anesthesia or sedation

You may not qualify if:

• Contraindications to CMRI.\*
• Pregnancy\*\*
• \* Contraindications to CMRI (i.e., magnetically activated implants/devices; cardiac pacemaker or wires; after the patients are scheduled for CMRI, they will be sent our standard pre-MRI paperwork/questionnaire, to determine eligibility to have an MRI)
• \*\*If a female patient of child bearing age is not sure if they are pregnant or not, as part of the standard CMRI with contrast procedures, a urine pregnancy test will be done. If the result is positive the subject will not be allowed to continue in the study. CMRI with gadolinium may affect a fetus, and also the CMRI results are an integral part of this research study.
• Orbital X-Ray confirmed to have metal in the eye or patient confirmed to have metal in the eye.
• Not enrolled in part A of the study
• Contraindications to CMRI\*
• Pregnancy \*\*
• Orbital X-Ray confirmed to have metal in the eye or patient confirmed to have metal in the eye
• Total Cumulative dose anthracyclines ≥300 mg/m2
• Contraindications to CMRI\*
• Pregnancy \*\*
• Orbital X-Ray confirmed to have metal in the eye or patient confirmed to have metal in the eye
• Contraindications to CMRI
• Relapse of their cancer

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Olga Salazar, MS

  Connecticut Childrens Med Ctr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardio-oncology nurse program manager

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 23, 2012
• Study Start: November 15, 2011
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)