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NCT Number: NCT03790943

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University Hospital Basel, Basel, Canton of Basel-City, Switzerland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiac assessment

Diagnostic Test

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

Primary outcomes

  1. Prevalence of cardiac dysfunction

    Time frame: Baseline and longitudinal follow-up where clinically indicated

    Conventional echocardiography: left ventricular ejection fraction (%)

  2. Prevalence of cardiac dysfunction

    Time frame: Baseline and longitudinal follow-up where clinically indicated

    Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS)

  3. Prevalence of impaired exercise capacity

    Time frame: Baseline

    Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production

  4. Treatment-related risk factors

    Time frame: Baseline

    Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)

  5. Treatment-related risk factors

    Time frame: Baseline

    Dose of chest radiation (Gray)

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Schindera, MD

CONTACT

[email protected]

+41 31 684 37 71

Claudia E Kuehni, MD

CONTACT

[email protected]

+41 31 684 35 07

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: Cardio-Onco

Important dates

Study start
2018
Primary completion
2029
Study completion
2029
First posted
Jan 2, 2019
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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