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Cardiac Dysfunction in Childhood Cancer Survivors

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03790943
Acronym
Cardio-Onco
Enrollment
500
Registered
2019-01-02
Start date
2018-02-13
Completion date
2029-04-23
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Dysfunction, Cardiovascular Diseases, Childhood Cancer

Keywords

Childhood cancer survivors, Late effects, Cardiotoxicity, Chemotherapy, Anthracyclines, Radiation

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).

Interventions

DIAGNOSTIC_TESTcardiac 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

Sponsors

University Hospital, Basel, Switzerland
CollaboratorOTHER
University Children's Hospital Basel
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
CollaboratorOTHER
Cantonal Hospital of St. Gallen
CollaboratorOTHER
Luzerner Kantonsspital
CollaboratorOTHER
University Hospital, Geneva
CollaboratorOTHER
University of Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of cardiac dysfunctionBaseline and longitudinal follow-up where clinically indicatedConventional echocardiography: left ventricular ejection fraction (%)
Prevalence of impaired exercise capacityBaselineCardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production
Treatment-related risk factorsBaselineCumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)

Countries

Switzerland

Contacts

Primary ContactClaudia E Kuehni, MD
claudia.kuehni@unibe.ch+41 31 684 35 07
Backup ContactChristina Schindera, MD
christina.schindera@unibe.ch+41 31 684 37 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026