Early Detection of Cardiac Toxicity in Childhood Cancer Survivors

NCT03038997 | Terminated

• 1 other identifier: 5405
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• Echocardiogram marker measurements pre ABC chemo and post ABC

  •Measure echocardiogram markers on pre anthracycline based chemotherapy (ABC) and post ABC echocardiograms, using standard echocardiogram measurements and speckle tracking.

  At the end of each cardiac MRI exam through study completion, up to 5 years

Secondary Outcomes (2)

• Detection of cardiac toxicity on MRI and echocardiogram

  At the end of each cardiac MRI exam through study completion, up to 5 years

• Serum biomarkers correlation

  At the end of the study, up to 10 years

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with previous exposure to anthracyclines between the ages of 8-25 years of age.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Niti Dham: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (27)

• Schwartz RG, Jain D, Storozynsky E. Traditional and novel methods to assess and prevent chemotherapy-related cardiac dysfunction noninvasively. J Nucl Cardiol. 2013 Jun;20(3):443-64. doi: 10.1007/s12350-013-9707-1.

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• 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. No abstract available.

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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.

MeSH Terms

Conditions

Heart Failure; Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Niti Dham, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: November 1, 2014
• Primary Completion: March 11, 2018
• Study Completion: March 11, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)