1- To estimate the prevalence of cardiac abnormalities, defined as systolic dysfunction, cardiovascular risk factors in CCS who have received anthracyclines, mitoxantrone and / or radiotherapy to the heart region compared with sibling controls and…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1- Prevalence of abnormal systolic function (SF) in CCS treated with possible
cardiotoxic treatment compared to siblings
2- Prevalence of other cardiac abnormalities, cardiovascular risk factors,
abnormal biomarkers, ECG abnormalities compared to siblings
3- Treatment related risk factors for abnormal diagnostic values
4- Diagnostic value of echocardiographic measurements and biomarkers for an
abnormal systolic or diastolic function
Secondary outcome
n/a
Background summary
Advances in diagnosis and treatment of childhood cancer over the last decades
have dramatically increased long-term survival. As a result, the numbers of
childhood cancer survivors (CCS) are growing and it has become increasingly
clear that the former disease and its treatment can significantly impair
long-term health. The need for long-term follow-up is uniformly recognized.
Research focusing on identification and characterization of high-risk
populations is an essential foundation on which to build evidence-based
recommendations for long-term follow-up. Furthermore, research focusing on more
accurate screening tests and effective interventions is needed to reduce excess
morbidity and mortality in CCS. The SKION LATER Q2008 - cardiology study
phocuses on late cardiac toxicity in CCS
Study objective
1- To estimate the prevalence of cardiac abnormalities, defined as systolic
dysfunction, cardiovascular risk factors in CCS who have received
anthracyclines, mitoxantrone and / or radiotherapy to the heart region compared
with sibling controls and to estimate treatment related risk factors.
2- To estimate the diagnostic value of strain measurements (tissue Doppler
echocardiographic) to detect systolic and diastolic dysfunction in CCS who have
received anthracyclines, mitoxantrone or radiotherapy to the heart region
3- To estimate the prevalence of cardiac abnormalities, defined as systolic
dysfunction, cardiovascular risk factors in CCS who have received
cyclofosfamide, ifosfamide or vincristin compared with sibling controls and to
estimate treatment related risk factors.
4- To estimate the prevalence of abnormal biomarkers in CSS who had received
cardiotoxic treatment compared with siblings controls and to estimate the
treatment related risk factors;
5- To estimate the diagnostic value abnormal biomarkers to detect systolic or
diastolic dysfunction
Study design
The study will consist of an anamnesis and physical exam, a echocardiography,
an ECG and a venapuncture. for a substantial part of the population, these
tests will be part of regular patient follow up as defined by the guidelines
for screening for late toxicity in CCS. Data will be collected anonymously in a
central database. .
Study burden and risks
the largest part of the participants (n=3000) will get a outpatient visit,
echocardiogram and venapuncture as part of their regular follow up based on
screening guidelines for CCS. only the ECG is only part of the study for these
patients (15 minutes) for the CCS treated with cyclophosphamide, ifosfamide or
vincristin, the outpatient visit and venapuncture is part of the regular follow
up based on screening guidelines for CCS. for these CCS the echocardiography
and venapuncture are done as part of the study (1.15 hrs) for the matched
sibbling controls, outpatient visit, echocardiography, ECG and venapuncture are
done in research setting (2.5 hrs) there are no risks for the study
participants.
Heidelberglaan 25
Utrecht 3584CS
NL
Heidelberglaan 25
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
All patients who were treated for childhood cancer (before age 18) in one of
the Pediatric Oncology Centers between 1960 and 2001 and who survived for at
least 5 years after diagnosis will be included in the SKION LATER study.
Participating centres are located in Amsterdam (VU University Medical Center
(VUMC)), Groningen (Children's Cancer Center/ University Medical Center
Groningen (UMCG)), Rotterdam (Rotterdam Erasmus MC-Sophia (REMC-S), Nijmegen
(University Medical Center Nijmegen (UMCN)), Leiden (Leiden University Medical
Center (LUMC) and Utrecht (Princess Máxima Center for Pediatric Oncology
(PMC)). From this cohort, 3400 childhood cancer survivors will be asked to
participate in the cardiology study secondly, 500 controls will be recruited,
siblings of the included patients.
Exclusion criteria
diagnosis of childhood cancer with survival less than 5 years, age at diagnosis
>17 years or diagnosis while residing in foreign country no cardiotoxic
treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL34907.018.10 |