• To evaluate the proportion of childhood cancer survivors that reach peak bone mass• To evaluate the incidence rate of fractures of CCS as compared to normal controls• To investigate patients at (treatment or diagnosis related) risk for decline of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
botten, bewegingsapparaat en fitheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1- Prevalence and exogenous and genetic risk factors of osteopenia and
osteoporosis and subsequent fractures, per persons years in CCS. 2- Prevalence
of over- and underweight as expressed by BMI and LBM. 3- Treatment and
diagnosis related risk factors for irreversible osteonecrosis. 4- Treatment and
diagnosis related risk factors for impaired motor function and muscle strength
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. This DCOG LATER Q2008 - study phocuses on late
toxicity involving bone, bodycomposition (underweight and overweight), motor
performance and muscle mass and strength, which are indicators of frailty
Study objective
• To evaluate the proportion of childhood cancer survivors that reach peak bone
mass
• To evaluate the incidence rate of fractures of CCS as compared to normal
controls
• To investigate patients at (treatment or diagnosis related) risk for decline
of BM(A)D at an earlier age as compared to the normal population. (baseline for
future longitudinal studies)
• To identify childhood cancer survivors at risk for osteoporosis based on
evaluation of genetic variation
• To evaluate the prevalence of osteopenia in a full cohort of childhood cancer
survivors in relation to Calcium intake and physical activity
• To study the correlation between age of menopause and bone mineral density
• To identify childhood cancer survivors at risk for osteoporosis based on
evaluation of folate metabolism
• The body composition as measured by DXA with in a full cohort of childhood
cancer survivors in order to be able to evaluate type of cancer, therapy and
exogenic factors as risk factors for an altered body composition after
surviving childhood cancer.
• To study the long term outcome of patients with osteonecrosis during therapy
• To investigate the risk of and risk factors of irreversible osteonecrosis as
a long term side effect of treatment childhood cancer
• To investigate the motor performance and fitness status of long term
survivors of childhood cancer
• To investigate denominators of impaired motor performance and fitness after
childhood cancer (disease, chemo, surgery)
• To investigate the impact of osteonecrosis and fracture rate on motor ability
status in long term survivors of childhood cancer
• To evaluate impaired muscle mass and muscle strenght in long term survivors
of childhood cancer
• To evaluate the prevalence of (pre)frailty in long term survivors of
childhood cancer
Study design
The study with cross sectional design will consist of an anamnesis and physical
examination, a DXA scan, a questionnaire, a 6 minute walking test, strength and
mobility tests and a venapuncture. For a substantial part of the study
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=2500 will get an outpatient visit, DXA
scan and venapuncture as part of their regular follow up based on screening
guidelines for CCS. For this group only the questionnaire (10 minutes), and the
6 minute walking test. For the patients for which DXA scan is not included in
the guideline extra time (30 minutes) and radiation exposition has to be
considered (dose equivalent of ± 10µSv). This dose is equivalent to 1 or 2
days natural radiation exposition in the open air in the Netherlands.
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 DCOG 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, 2500 childhood cancer survivors will be asked to
participate in this study. (BMI will be assessed in all 7000 survivors as
regular patient care).
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 cardiologic
impairment(fitness)
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 | NL35000.018.11 |