Cardiac DysfunctionCardio-OncoNCT03790943
Cardiac Dysfunction in Childhood Cancer Survivors
An observational study of Cardiac Dysfunction and Cardiovascular Diseases, run by University of Bern at 6 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Dysfunction, Cardiovascular Diseases, Childhood Cancer
- What is being tested?
- cardiac assessment
- How many people
- 500 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 13 Feb 2018to 23 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Study participants will be excluded if they do not meet the above mentioned inclusion criteria or refuse to participate in the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Switzerland6 sites, 5 recruiting
- Recruiting
Department of Cardiology, University Hospital Basel
Basel, Canton of Basel-City, 4031
Gabriela Kuster, MD
- Active, not recruiting
Institute of Social and Preventive Medicine, University of Bern
Bern, Canton of Bern, 3012
- Recruiting
Department of Cardiology, Inselspital Bern
Bern, 3010
Stephan Dobner, MD
Thomas Suter, MD
- Recruiting
Department of Cardiology, University Hospitals of Geneva
Geneva, 1205
Nana K Poku, MD
- Recruiting
Department of Cardiology, Lucerne Cantonal Hospital
Lucerne, 6000
Reto Kurmann, MD
- Recruiting
Department of Cardiology, Cantonal Hospital of St. Gallen
Sankt Gallen, 9007
Eva Scheler, MD
About this study
Official title: Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
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.
Read the 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).
- Being tested
- cardiac assessment
- Keywords
- Childhood cancer survivors, Late effects, Cardiotoxicity, Chemotherapy, Anthracyclines, Radiation
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiac dysfunction
Conventional echocardiography: left ventricular ejection fraction (%)
Measured: Baseline and longitudinal follow-up where clinically indicated
Prevalence of cardiac dysfunction
Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS)
Measured: Baseline and longitudinal follow-up where clinically indicated
Prevalence of impaired exercise capacity
Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production
Measured: Baseline
Treatment-related risk factors
Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)
Measured: Baseline
Treatment-related risk factors
Dose of chest radiation (Gray)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start13 Feb 2018
- Primary completion23 Apr 2029 (estimated)
- Study completion23 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DysfunctionStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Insel Gruppe AG, University Hospital Bern, Cantonal Hospital of St. Gallen, Luzerner Kantonsspital, University Hospital, Geneva, University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Claudia E Kuehni, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790943
- Sponsor's protocol ID
- SCCSS_cardiac_FU
- Acronym
- Cardio-Onco
- Status last verified
- May 2026
- First submitted
- 25 Jun 2018
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32269016
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT03790943
- Acronym / sponsor ID
- Cardio-Onco / SCCSS_cardiac_FU
- Keywords
- Childhood cancer survivors, Late effects, Cardiotoxicity, Chemotherapy, Anthracyclines, Radiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Insel Gruppe AG, University Hospital Bern, Cantonal Hospital of St. Gallen, Luzerner Kantonsspital, University Hospital, Geneva, University Children's Hospital Basel
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 23 Apr 2029 (estimated)
- Study completion
- 23 Apr 2029 (estimated)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Study participants will be excluded if they do not meet the above mentioned inclusion criteria or refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac assessmentPersonal 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 | Diagnostic test | – |
Primary outcome
Prevalence of cardiac dysfunction
Time frame: Baseline and longitudinal follow-up where clinically indicated
Conventional echocardiography: left ventricular ejection fraction (%)
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)
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
Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)
Treatment-related risk factors
Time frame: Baseline
Dose of chest radiation (Gray)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 32269016Schindera 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia E Kuehni, MD principal investigator
University of Bern
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Dysfunction and Cardiovascular Diseases, run by University of Bern at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia E Kuehni, MD (+41 31 684 35 07, claudia.kuehni@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cardiac dysfunction (time frame: Baseline and longitudinal follow-up where clinically indicated). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.