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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01671696
Recruitment Status : Recruiting
First Posted : August 23, 2012
Last Update Posted : February 15, 2017
Information provided by (Responsible Party):
Olga Salazar, Connecticut Children's Medical Center

Brief Summary:
The main hypothesis being tested is that imaging and serologic biomarkers of apoptosis and progressive 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Other: Cardiac MRI

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy: A Cardiac Magnetic Resonance and Biomarker Imaging and Serological Biomarker Study
Study Start Date : September 2011
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Cardiac MRI
    Cardiac MRI

Primary Outcome Measures :
  1. To see if a CMRI is better at detecting occult asymptomatic cardiotoxicity [ Time Frame: 1 year ]
    Changes in T1 mapping-derived relaxation time and left ventricular myocardial peak circumference strain 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.

Secondary Outcome Measures :
  1. Have a low shortening fraction is an indicator of cardiotoxicity [ Time Frame: 1 year ]
    Shortening Fraction < 29% during chemotherapy or at follow-up, even if transient, serves as an early marker for cardiotoxicity (Lower EF, LV Mass, and increased ESWS).

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Ages Eligible for Study:   9 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

  • Childhood cancer survivors from the late effect clinic who had been in continuous, complete remission and off chemotherapy for a minimum of 2 years.
  • Age > 9 years of age

Exclusion Criteria:

  • Contraindications to CMRI
  • Relapse of their cancer
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01671696

United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Nancy Cronin    860-837-5881      
Sponsors and Collaborators
Connecticut Children's Medical Center
Principal Investigator: Olga Salazar, MS Connecticut Childrens Med Ctr

Responsible Party: Olga Salazar, Assistant Clinical Professor, Pediatric Cardiology, Connecticut Children's Medical Center Identifier: NCT01671696     History of Changes
Other Study ID Numbers: 10-096 CCMC
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: pending PI review.

Additional relevant MeSH terms:
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries