• To study denominators of the metabolic syndrome in all survivors of childhood cancer• To compare the occurrence with previous disease and treatment components to identify subgroups at risk Metabolic syndrome• To study the overall frequency of the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prevalence of metabolic syndrome or its denominators (body composition,
hypertension, DM, Fat spectrum)
Secondary outcome
nvt
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 - metabolic study
phocuses on the prevalence of the metabolic syndrome in CCS . since the
metabolic syndrome predisposes patients for cardiovascular disease, for which
CCS are at risk for other reasons as well, this subject seems very relevant in
this patient group
Study objective
• To study denominators of the metabolic syndrome in all survivors of childhood
cancer
• To compare the occurrence with previous disease and treatment components to
identify subgroups at risk Metabolic syndrome
• To study the overall frequency of the metabolic syndrome in a full cohort of
childhood cancer survivors
• To study the denominators of the metabolic syndrome in all survivors of
childhood cancer separately in order to be able to identify risk groups for
these endpoints after surviving childhood cancer: (body composition,
hypertension, DM, Fat spectrum)
• To study the correlation of these denominators of metabolic syndrome with
previous disease and treatment components to identify risk factors
• To correlate the value of of biomarkers (leptine, ,adiponectiine etc) and
proinflammatory markers (TNF, alpha, Il6) with the risk of metabolic syndrome
Study design
The study involves a cross-sectional study of a retrospective nationwide cohort
of 5-year survivors of childhood cancer (diagnosed 1960-2003) in the
Netherlands. besides, 500 sibling controls of survivors will be approached. We
estimate that the total cohort will include 7000 survivors and controls
Study burden and risks
The survivors will be invited for the Q2008 SKION LATER study close to a visit
to the LATER out patient clinic. this visit will be combined with the out
patient visit for regular patient care. extra blood will be drawn during a
venapuncture for regular patient care. the only real burden of the study is
that the CCS will can not eat 8 hours in advance of the venapuncture.
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 2004 and who survived for at
least 5 years after diagnosis will be included in the SKION LATER- metabolic
syndrome 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)).
Exclusion criteria
diagnosis of childhood cancer with survival less than 5 years, age at diagnosis
>17 years or diagnosis while residing in foreign country
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 | NL32117.018.10 |