Clinical trial · Observational
Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
NCT03038997CI-TRIAL-00035999terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB approval expired
Summary
Brief summary (as posted)
To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (ABC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Echocardiogram marker measurements pre ABC chemo and post ABC
- timeFrame
- At the end of each cardiac MRI exam through study completion, up to 5 years
- description
- •Measure echocardiogram markers on pre anthracycline based chemotherapy (ABC) and post ABC echocardiograms, using standard echocardiogram measurements and speckle tracking.
Secondary outcomes (2)
- measure
- Detection of cardiac toxicity on MRI and echocardiogram
- timeFrame
- At the end of each cardiac MRI exam through study completion, up to 5 years
- description
- •Measure sensitivity of detecting cardiac toxicity between standard echocardiogram, speckle tracking on echo, and MRI
- measure
- Serum biomarkers correlation
- timeFrame
- At the end of the study, up to 10 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (27)
- BACKGROUNDSchwartz 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. PMID 23572315
- BACKGROUNDLipshultz 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. PMID 24081971
- BACKGROUNDKremer LC, van Dalen EC, Offringa M, Voute PA. Frequency and risk factors of anthracycline-induced clinical heart failure in children: a systematic review. Ann Oncol. 2002 Apr;13(4):503-12. doi: 10.1093/annonc/mdf118. PMID 12056699
- BACKGROUNDKremer LC, van der Pal HJ, Offringa M, van Dalen EC, Voute PA. Frequency and risk factors of subclinical cardiotoxicity after anthracycline therapy in children: a systematic review. Ann Oncol. 2002 Jun;13(6):819-29. doi: 10.1093/annonc/mdf167. PMID 12123328
- BACKGROUNDShankar SM, Marina N, Hudson MM, Hodgson DC, Adams MJ, Landier W, Bhatia S, Meeske K, Chen MH, Kinahan KE, Steinberger J, Rosenthal D; Cardiovascular Disease Task Force of the Children's Oncology Group. Monitoring for cardiovascular disease in survivors of childhood cancer: report from the Cardiovascular Disease Task Force of the Children's Oncology Group. Pediatrics. 2008 Feb;121(2):e387-96. doi: 10.1542/peds.2007-0575. Epub 2008 Jan 10. PMID 18187811