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Early Detection of Cardiac Toxicity in Childhood Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03038997
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Niti Dham, Children's 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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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.


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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03038997


Contacts
Contact: Niti Dham, MD 202-476-2020 ndham@childrensnational.org
Contact: Karin Hamann, RNC 202-476-2317 khamann@childrensnational.org

Locations
United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Niti Dham, MD    202-476-2020    ndham@childrensnational.org   
Sponsors and Collaborators
Niti Dham
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Niti Dham, MD Children's National

Publications:
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.

Responsible Party: Niti Dham, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT03038997     History of Changes
Other Study ID Numbers: 5405
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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