Cardiovascular Diseases Clinical Trial
— Cardio-OncoOfficial title:
Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | January 1, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Cardiology, University Hospital Basel | Basel | Basel-City |
Switzerland | Department of Cardiology, Inselspital Bern | Bern | |
Switzerland | Institute of Social and Preventive Medicine, University of Bern | Bern | BE |
Switzerland | Department of Cardiology, University Hospitals of Geneva | Geneva | |
Switzerland | Department of Cardiology, Lucerne Cantonal Hospital | Lucerne | |
Switzerland | Department of Cardiology, Cantonal Hospital of St. Gallen | Saint Gallen |
Lead Sponsor | Collaborator |
---|---|
University of Bern | Cantonal Hospital of St. Gallen, Insel Gruppe AG, University Hospital Bern, Luzerner Kantonsspital, University Children's Hospital Basel, University Hospital, Basel, Switzerland, University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of cardiac dysfunction | Conventional echocardiography: left ventricular ejection fraction (%) | Baseline and longitudinal follow-up where clinically indicated | |
Primary | Prevalence of cardiac dysfunction | Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS) | Baseline and longitudinal follow-up where clinically indicated | |
Primary | Prevalence of impaired exercise capacity | Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production | Baseline | |
Primary | Treatment-related risk factors | Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2) | Baseline | |
Primary | Treatment-related risk factors | Dose of chest radiation (Gray) | Baseline |
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