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Early Detection of Cardiac Toxicity in Childhood Cancer Survivors

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. Read our disclaimer for details. Identifier: NCT03038997
Recruitment Status : Terminated (IRB approval expired)
First Posted : February 1, 2017
Last Update Posted : December 4, 2018
Information provided by (Responsible Party):
Niti Dham, Children's National Research Institute

Brief Summary:
To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (ABC).

Condition or disease
Heart Failure Cardiotoxicity

Detailed Description:
Cardiac toxicity is a significant potential complication for patients receiving anthracycline chemotherapy. Cells in the cardiovascular system have limited regenerative capability, making them susceptible to long term adverse effects from these chemotherapeutic agents. The ability to detect subclinical changes in cardiac function will allow clinicians to use proven treatments to prevent further progression in this vulnerable population. The current standard testing uses echocardiography, which is not as sensitive as cardiac MRI or serum biomarkers.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
Study Start Date : November 2014
Actual Primary Completion Date : March 11, 2018
Actual Study Completion Date : March 11, 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Echocardiogram marker measurements pre ABC chemo and post ABC [ Time Frame: At the end of each cardiac MRI exam through study completion, up to 5 years ]
    •Measure echocardiogram markers on pre anthracycline based chemotherapy (ABC) and post ABC echocardiograms, using standard echocardiogram measurements and speckle tracking.

Secondary Outcome Measures :
  1. Detection of cardiac toxicity on MRI and echocardiogram [ Time Frame: At the end of each cardiac MRI exam through study completion, up to 5 years ]
    •Measure sensitivity of detecting cardiac toxicity between standard echocardiogram, speckle tracking on echo, and MRI

  2. Serum biomarkers correlation [ Time Frame: At the end of the study, up to 10 years ]
    •Correlate measurement of serum biomarkers with prevalence of cardiac changes measured on echocardiograms and MRI imaging.

Biospecimen Retention:   Samples Without DNA
A blood specimen equal to 1 teaspoonful will be collected for future analysis to be used to identify serum biomarkers in myocardial fibrosis, and to validate the potential use for diagnostic purposes.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with previous exposure to anthracyclines between the ages of 8-25 years of age.

Inclusion Criteria:

  • Subjects that have received anthracycline based chemotherapy
  • Age: 8 years old - 25 years old
  • Subjects that do not require sedation for cardiac MRI.
  • Subjects must have completed treatment in the last 10 years

Exclusion Criteria:

  • Patients with significant congenital heart defects
  • Patients with renal injury or renal failure, defined as an estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2 body surface area), as previously calculated)
  • Patients that require sedation for a cardiac MRI
  • Subjects that are pregnant or lactating
  • Patients with contraindications to a cardiac MRI:
  • Cardiac pacemaker or implantable defibrillator
  • Cerebral aneurysm clip
  • Neural stimulator
  • Metallic ocular foreign body
  • Any implanted device (i.e. insulin pump, drug infusion device)
  • Claustrophobia
  • Metal shrapnel or bullet
  • Investigator assessment of inability to comply with protocol
  • Unable/unwilling to lie still throughout the research procedure
  • Persons with cognitive impairment

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): NCT03038997

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United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Niti Dham
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Principal Investigator: Niti Dham, MD Children's National
Lipshultz SE, Adams MJ, Colan SD, Constine LS, Herman EH, Hsu DT, Hudson MM, Kremer LC, Landy DC, Miller TL, Oeffinger KC, Rosenthal DN, Sable CA, Sallan SE, Singh GK, Steinberger J, Cochran TR, Wilkinson JD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Basic Cardiovascular Sciences, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Radiolo. Long-term cardiovascular toxicity in children, adolescents, and young adults who receive cancer therapy: pathophysiology, course, monitoring, management, prevention, and research directions: a scientific statement from the American Heart Association. Circulation. 2013 Oct 22;128(17):1927-95. doi: 10.1161/CIR.0b013e3182a88099. Epub 2013 Sep 30. Erratum in: Circulation. 2013 Nov 5;128(19):e394.

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Responsible Party: Niti Dham, MD, Children's National Research Institute Identifier: NCT03038997    
Other Study ID Numbers: 5405
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries