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Clinical Trials/NCT03790943
NCT03790943
Recruiting
Not Applicable

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

University of Bern6 sites in 1 country500 target enrollmentFebruary 13, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Dysfunction
Sponsor
University of Bern
Enrollment
500
Locations
6
Primary Endpoint
Prevalence of impaired exercise capacity
Status
Recruiting
Last Updated
12 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 13, 2018
End Date
April 23, 2029
Last Updated
12 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Prevalence of impaired exercise capacity

Time Frame: Baseline

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

Treatment-related risk factors

Time Frame: Baseline

Dose of chest radiation (Gray)

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)

Study Sites (6)

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