Cardiac Dysfunction in Childhood Cancer Survivors

Cardiovascular Diseases Clinical Trial

— Cardio-Onco  

Official title:

Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03790943
• Other study ID #: SCCSS_cardiac_FU
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cardiac Dysfunction
• Cardiovascular Diseases
• Childhood Cancer

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