Cardiac Dysfunction in Childhood Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cardiac assessment.
- Who it may be relevant to
- Registry conditions: Cardiac Dysfunction, Cardiovascular Diseases, Childhood Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
Overview
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
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).
Interventions
- 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
Primary outcome measures
- Prevalence of cardiac dysfunction [Time frame: Baseline and longitudinal follow-up where clinically indicated]
- Prevalence of cardiac dysfunction [Time frame: Baseline and longitudinal follow-up where clinically indicated]
- Prevalence of impaired exercise capacity [Time frame: Baseline]
- Treatment-related risk factors [Time frame: Baseline]
- Treatment-related risk factors [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 6 centers
- Department of Cardiology, University Hospital Basel — Basel
- Institute of Social and Preventive Medicine, University of Bern — Bern
- Department of Cardiology, Inselspital Bern — Bern
- Department of Cardiology, University Hospitals of Geneva — Geneva
- Department of Cardiology, Lucerne Cantonal Hospital — Lucerne
- Department of Cardiology, Cantonal Hospital of St. Gallen — Sankt Gallen
Publications
- Schindera C, Kuehni CE, Pavlovic M, Haegler-Laube ES, Rhyner D, Waespe N, Roessler J, Suter T, von der Weid NX. Diagnosing Preclinical Cardiac Dysfunction in Swiss Childhood Cancer Survivors: Protocol for a Single-Center Cohort Study. JMIR Res Protoc. 2020 Jun 10;9(6):e17724. doi: 10.2196/17724. PMID 32269016
Identifiers
NCT: NCT03790943 · SCCSS_cardiac_FU