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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03790943
Other study ID # SCCSS_cardiac_FU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 13, 2018
Est. completion date January 1, 2024

Study information

Verified date December 2023
Source University of Bern
Contact Claudia E Kuehni, MD
Phone +41 31 684 35 07
Email claudia.kuehni@unibe.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

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.

Study Design


Intervention

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

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

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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