Early detection of cardiac dysfunction in childhood cancer survivors; a DCOG LATER study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23641

Enrollment

2200

Registered

2018-07-11

Start date

2017-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity in childhood cancer survivors

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Eligible survivors are 5-year childhood cancer survivors (CCS) diagnosed before the age of 18 years, between 1/1/1963 and 12/31/2001 with a malignancy according to the third edition of the International Classification of Childhood Cancer. We only included CCS who were living in the Netherlands at the time of childhood cancer diagnosis and who were treated in one of the Dutch pediatric oncology/hematology centers (Academic Medical Center Amsterdam, VU University Medical Center, Leiden University Medical Center, Erasmus Medical Center, University Medical Center Groningen, Radboudumc, and University Medical Center Utrecht). This study will include 4 risk groups; risk group 1: CCS who have received anthracyclines, mitoxantrone, or irradiation to the heart region; risk group 2 (max n=100): cyclophosphamide only (no anthracyclines, mitoxantrone, or irradiation to the heart region, ifosfamide or vincristine); risk group 3 (max n=100): ifosfamide only (no anthracyclines, mitoxantrone, or irradiation to the heart region, cyclophosphamide or vincristine); risk group 4 (max n=100): vincristine only (no anthracyclines, mitoxantrone, or irradiation to the heart region, ifosfamide or cyclophosphamide), irrespective current age. For the comparison group 500 healthy siblings will be included.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
With the current project we would like to answer the following research questions: 1.What is the prevalence and what are treatment related and lifestyle related risk factors for late (>10 year follow up) asymptomatic systolic or diastolic cardiac dysfunction identified by echocardiography in CCS compared with sibling controls? 2.What is the prevalence and what are treatment related risk factors for abnormal biomarkers in CCS compared with sibling controls? 3.What is the prevalence and what are treatment related risk factors for abnormal ECG measurements in CCS compared with sibling controls? 4.What are early diagnostic markers for cardiac dysfunction, defined by echocardiographic measurements, in blood and ECG by a cross sectional measurement in CCS and controls. 5.What are the gender differences in prevalence, risk factors for late abnormal echocardiographic measurements, late concurrent abnormal biomarkers and late concurrent ECG abnormalities 6.What are optimal recommendations for the cardiac follow-up of CCS	—

Measure

Time frame

With the current project we would like to answer the following research questions: 1.What is the prevalence and what are treatment related and lifestyle related risk factors for late (>10 year follow up) asymptomatic systolic or diastolic cardiac dysfunction identified by echocardiography in CCS compared with sibling controls? 2.What is the prevalence and what are treatment related risk factors for abnormal biomarkers in CCS compared with sibling controls? 3.What is the prevalence and what are treatment related risk factors for abnormal ECG measurements in CCS compared with sibling controls? 4.What are early diagnostic markers for cardiac dysfunction, defined by echocardiographic measurements, in blood and ECG by a cross sectional measurement in CCS and controls. 5.What are the gender differences in prevalence, risk factors for late abnormal echocardiographic measurements, late concurrent abnormal biomarkers and late concurrent ECG abnormalities 6.What are optimal recommendations for the cardiac follow-up of CCS

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Outcome results