Cardiac Dysfunction in Childhood Cancer Survivors

Recruiting

• Conditions: Childhood Cancer; Cardiovascular Diseases; Cardiac Dysfunction

• Registration Number: NCT03790943
• Lead Sponsor: University of Bern

Brief 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.

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).

Study Timeline

• Study Start: 2018-02-13
• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-12-29
• Study First Posted: 2019-01-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2029-04-23
• Study Completion: 2029-04-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of impaired exercise capacity	Baseline	Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production
Treatment-related risk factors	Baseline	Dose of chest radiation (Gray)
Prevalence of cardiac dysfunction	Baseline and longitudinal follow-up where clinically indicated	Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS)

Trial Locations

Locations (6)

Institute of Social and Preventive Medicine, University of Bern; 🇨🇭 Bern, BE, Switzerland

Department of Cardiology, University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland

Department of Cardiology, Inselspital Bern; 🇨🇭 Bern, Switzerland

Department of Cardiology, Lucerne Cantonal Hospital; 🇨🇭 Lucerne, Switzerland

Department of Cardiology, Cantonal Hospital of St. Gallen; 🇨🇭 Saint Gallen, Switzerland

Department of Cardiology, University Hospital Basel; 🇨🇭 Basel, Basel-City, Switzerland