Cardiac Dysfunction in Childhood Cancer Survivors (Cardio-Onco)

Prospective Single Center Cohort Study for Early Detection of 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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Childhood Cancer; Cardiac Dysfunction
• Intervention / Treatment: Diagnostic test: cardiac assessment

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Claudia E Kuehni, MD; Phone Number: +41 31 684 35 07; Email: claudia.kuehni@unibe.ch
• Study Contact Backup: Name: Christina Schindera, MD; Phone Number: +41 31 684 37 71; Email: christina.schindera@unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Cardiology, Inselspital Bern
    • Principal Investigator: Thomas Suter, MD
    • Contact: Stephan Dobner, MD
  • Geneva, Switzerland, 1205
    • Recruiting
    • Department of Cardiology, University Hospitals of Geneva
    • Contact: Nana K Poku, MD
  • Lucerne, Switzerland, 6000
    • Recruiting
    • Department of Cardiology, Lucerne Cantonal Hospital
    • Contact: Reto Kurmann, MD
  • Saint Gallen, Switzerland, 9007
    • Recruiting
    • Department of Cardiology, Cantonal Hospital of St. Gallen
    • Contact: Eva Scheler, MD
  • BE
    • Bern, BE, Switzerland, 3012
      • Active, not recruiting
      • Institute of Social and Preventive Medicine, University of Bern
  • Basel-City
    • Basel, Basel-City, Switzerland, 4031
      • Recruiting
      • Department of Cardiology, University Hospital Basel
      • Contact: Gabriela Kuster, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult survivors of childhood cancer, formerly treated at the University Children's Hospital Bern or University Children's Hospital Basel or Children's Hospital of Eastern Switzerland or Children´s Hospital Lucerne or University Hospitals of Geneva, with any chemotherapy and/or chest radiation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of cardiac dysfunction	Conventional echocardiography: left ventricular ejection fraction (%)	Baseline and longitudinal follow-up where clinically indicated
Prevalence of cardiac dysfunction	Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS)	Baseline and longitudinal follow-up where clinically indicated
Treatment-related risk factors	Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)	Baseline
Treatment-related risk factors	Dose of chest radiation (Gray)	Baseline
Prevalence of impaired exercise capacity	Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production	Baseline

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: University Hospital, Geneva; University Hospital, Basel, Switzerland; Luzerner Kantonsspital; Cantonal Hospital of St. Gallen; University Children's Hospital Basel; Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Claudia E Kuehni, MD, University of Bern

Publications and helpful links

General Publications

• Schindera C, Kuehni CE, Pavlovic M, Haegler-Laube ES, Rhyner D, Waespe N, Roessler J, Suter T, von der Weid NX. Diagnosing Preclinical Cardiac Dysfunction in Swiss Childhood Cancer Survivors: Protocol for a Single-Center Cohort Study. JMIR Res Protoc. 2020 Jun 10;9(6):e17724. doi: 10.2196/17724.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: December 29, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Chemotherapy; Cardiotoxicity; Anthracyclines; Radiation; Childhood cancer survivors; Late effects
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: SCCSS_cardiac_FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No