Cardiac Dysfunction in Childhood Cancer Survivors

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03790943

Studienbeginn:
Februar 2018

Letztes Update:
08.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Cardiovascular Diseases

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Bern

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

Studienleiter

Claudia E Kuehni, MD
Principal Investigator
University of Bern

Kontakt

Claudia E Kuehni, MD
Kontakt:
Phone: +41 31 684 35 07
E-Mail: claudia.kuehni@unibe.ch» Kontaktdaten anzeigen

Christina Schindera, MD
Kontakt:
Phone: +41 31 684 37 71
E-Mail: christina.schindera@unibe.ch» Kontaktdaten anzeigen

Studienlocations
(3 von 6)

Department of Cardiology, University Hospital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Gabriela Kuster, MD» Ansprechpartner anzeigen

Institute of Social and Preventive Medicine, University of Bern
3012 Bern
SwitzerlandAktiv, nicht rekrutierend» Google-Maps

Department of Cardiology, Inselspital Bern
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Stephan Dobner, MD» Ansprechpartner anzeigen

Department of Cardiology, University Hospitals of Geneva
1205 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Nana K Poku, MD» Ansprechpartner anzeigen

Department of Cardiology, Lucerne Cantonal Hospital
6000 Lucerne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Reto Kurmann, MD» Ansprechpartner anzeigen

Department of Cardiology, Cantonal Hospital of St. Gallen
9007 Saint Gallen
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Eva Scheler, MD» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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)

Geprüfte Regime

cardiac 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

Quelle: ClinicalTrials.gov

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