NCT03790943

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Feb 2018Apr 2029

Study Start

First participant enrolled

February 13, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2029

Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

11.2 years

First QC Date

June 25, 2018

Last Update Submit

May 6, 2025

Conditions

Cardiac DysfunctionCardiovascular DiseasesChildhood Cancer

Keywords

Childhood cancer survivorsLate effectsCardiotoxicityChemotherapyAnthracyclinesRadiation

Outcome Measures

Primary Outcomes (5)

  • 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

  • Prevalence of impaired exercise capacity

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

    Baseline

  • 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

Interventions

cardiac assessmentDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Cardiology, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Institute of Social and Preventive Medicine, University of Bern

Bern, Canton of Bern, 3012, Switzerland

ACTIVE NOT RECRUITING

Department of Cardiology, Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

Department of Cardiology, University Hospitals of Geneva

Geneva, 1205, Switzerland

RECRUITING

Department of Cardiology, Lucerne Cantonal Hospital

Lucerne, 6000, Switzerland

RECRUITING

Department of Cardiology, Cantonal Hospital of St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32269016DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesNeoplasmsCardiotoxicity

Condition Hierarchy (Ancestors)

Heart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Officials

  • Claudia E Kuehni, MD

    University of Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia E Kuehni, MD

CONTACT

+41 31 684 35 07claudia.kuehni@unibe.ch

Christina Schindera, MD

CONTACT

+41 31 684 37 71christina.schindera@unibe.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2018

First Posted

January 2, 2019

Study Start

February 13, 2018

Primary Completion (Estimated)

April 23, 2029

Study Completion (Estimated)

April 23, 2029

Last Updated

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(6)