Cardiac Dysfunction in Childhood Cancer Survivors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Study participants will be excluded if they do not meet the above mentioned inclusion criteria or refuse to participate in the study.
Trial population
Adult survivors of childhood cancer, formerly treated at the University Children's Hospital Bern or University Children's Hospital Basel or Children's Hospital of Eastern Switzerland or Children´s Hospital Lucerne or University Hospitals of Geneva, with any chemotherapy and/or chest radiation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
cardiac assessment
Diagnostic testPersonal 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Prevalence of cardiac dysfunction
Conventional echocardiography: left ventricular ejection fraction (%)
Time frame
Baseline and longitudinal follow-up where clinically indicated2
Prevalence of cardiac dysfunction
Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS)
Time frame
Baseline and longitudinal follow-up where clinically indicated3
Prevalence of impaired exercise capacity
Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production
Time frame
Baseline4
Treatment-related risk factors
Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)
Time frame
BaselineSponsors and contacts
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University of Bern
Lead sponsor
University Hospital, Basel, Switzerland
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Cantonal Hospital of St. Gallen
Collaborator
Luzerner Kantonsspital
Collaborator
University Hospital, Geneva
Collaborator
University Children's Hospital Basel
Collaborator
Source ClinicalTrials.gov