Cardiac Dysfunction in Childhood Cancer Survivors

Study Overview
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Brief Summary
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This multicenter, prospective cohort study evaluates early cardiac dysfunction in adult survivors of childhood cancer. The hypothesis of this study is that cardiac dysfunction can be detected earlier when using speckle tracking echocardiography as novel echocardiographic technique compared to conventional echocardiography.

Detailed Description
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Cardiovascular disease including cardiac dysfunction is the leading non-malignant cause of death in childhood cancer survivors. Early detection of cardiac dysfunction is important to identify those in need for medical intervention to improve outcome. This study invites adult childhood cancer survivors to a clinical appointment to the University Hospital Bern, Switzerland. A detailed, standardized cardiac assessment including conventional and novel echocardiographic techniques (speckle tracking) as well as cardiopulmonary exercise testing is performed. Cardiac dysfunction is evaluated in survivors who have had cardiotoxic cancer therapy with anthracyclines and/or chest radiation (high risk) and in survivors who have had chemotherapy other than anthracyclines (standard risk).

Official Title
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Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors

Conditions
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Cardiac Dysfunction, Cardiovascular Diseases, Childhood Cancer

Intervention / Treatment
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* Diagnostic Test: cardiac assessment


Participation Criteria
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Eligibility Criteria
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This prospective cohort study is nested within the Childhood Cancer Registry (ChCR), a national, population-based cancer registry that includes all children and adolescents in Switzerland who were diagnosed with cancer at age 0-20 years. It includes patients diagnosed with leukemia, lymphoma, central nervous system tumors, and malignant solid tumours or Langerhans cell histiocytosis. Childhood cancer survivors have survived at least 5 years from cancer diagnosis. Inclusion Criteria: Registered in the ChCR Formerly treated at the Department of Pediatric Hematology/Oncology of one of five participating centers Treated with any chemotherapy and/or chest radiation Survived ≥ 5 years since most recent cancer diagnosis (primary cancer, relapse(s), secondary cancer) at time of examination Diagnosed at age ≤ 20 years ≥ 18 years of age at time of study participation Resident in Switzerland Written informed consent Exclusion Criteria: Study participants will be excluded if they do not meet the above mentioned inclusion criteria or refuse to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: cardiac assessment|Personal history, physical examination including anthropometry with hip/waist-ratio, electrocardiogram, echocardiography, 1-minute-sit-to-stand test, questionnaires on health-related quality of life (SF-36), diet, physical activity, and fatigue|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of cardiac dysfunction | Conventional echocardiography: left ventricular ejection fraction (%) | Baseline and longitudinal follow-up where clinically indicated | 
| Prevalence of cardiac dysfunction | Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS) | Baseline and longitudinal follow-up where clinically indicated | 
| Prevalence of impaired exercise capacity | Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production | Baseline | 
| Treatment-related risk factors | Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2) | Baseline | 
| Treatment-related risk factors | Dose of chest radiation (Gray) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation, Childhood cancer survivors, Late effects, Cardiotoxicity, Chemotherapy, Anthracyclines