Clinical trial NCT03790943: Cardiac Dysfunction in Childhood Cancer Survivors
Official title: Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Dysfunction
Cardiovascular Diseases
Childhood Cancer
Keywords: Childhood cancer survivors
Late effects
Cardiotoxicity
Chemotherapy
Anthracyclines
Radiation
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
name: University Children's Hospital Basel
name: Insel Gruppe AG, University Hospital Bern
name: Cantonal Hospital of St. Gallen
name: Luzerner Kantonsspital
name: University Hospital, Geneva
First posted: 2019-01-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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.

Primary outcomes:
measure: Prevalence of cardiac dysfunction
timeFrame: Baseline and longitudinal follow-up where clinically indicated
measure: Prevalence of cardiac dysfunction
timeFrame: Baseline and longitudinal follow-up where clinically indicated
measure: Prevalence of impaired exercise capacity
timeFrame: Baseline
measure: Treatment-related risk factors
timeFrame: Baseline
measure: Treatment-related risk factors
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Cardiology, University Hospital Basel
state: Basel-City
city: Bern
country: Switzerland
facility: Institute of Social and Preventive Medicine, University of Bern
state: BE
city: Bern
country: Switzerland
facility: Department of Cardiology, Inselspital Bern
city: Geneva
country: Switzerland
facility: Department of Cardiology, University Hospitals of Geneva
city: Lucerne
country: Switzerland
facility: Department of Cardiology, Lucerne Cantonal Hospital
city: Saint Gallen
country: Switzerland
facility: Department of Cardiology, Cantonal Hospital of St. Gallen
Study officials:
affiliation: University of Bern
name: Claudia E Kuehni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.