Cardiac Dysfunction in Childhood Cancer Survivors

NCT ID: NCT03790943

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-13

Study Completion Date

2029-04-23

Brief Summary

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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

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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).

Conditions

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Cardiac Dysfunction Cardiovascular Diseases Childhood Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

University Children's Hospital Basel

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia E Kuehni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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Department of Cardiology, University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Institute of Social and Preventive Medicine, University of Bern

Bern, Canton of Bern, Switzerland

Site Status ACTIVE_NOT_RECRUITING

Department of Cardiology, Inselspital Bern

Bern, , Switzerland

Site Status RECRUITING

Department of Cardiology, University Hospitals of Geneva

Geneva, , Switzerland

Site Status RECRUITING

Department of Cardiology, Lucerne Cantonal Hospital

Lucerne, , Switzerland

Site Status RECRUITING

Department of Cardiology, Cantonal Hospital of St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Claudia E Kuehni, MD

Role: CONTACT

+41 31 684 35 07

Christina Schindera, MD

Role: CONTACT

+41 31 684 37 71

Facility Contacts

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Gabriela Kuster, MD

Role: primary

Stephan Dobner, MD

Role: primary

Nana K Poku, MD

Role: primary

Reto Kurmann, MD

Role: primary

Eva Scheler, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32269016 (View on PubMed)

Other Identifiers

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SCCSS_cardiac_FU

Identifier Type: -

Identifier Source: org_study_id

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