Medical assessment of adverse health outcomes in Dutch childhood cancer survivors; a nationwide project; SKION LATER Q2008 onderzoek: Thyroid function, in children and adults, after treatment for childhood cancer

Completed

Conditions: 10043739
thyroid dysfunction

Registration Number: NL-OMON47586

Lead Sponsor: Stichting Kinderoncologie Nederland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2281

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, 1481 childhood cancer survivors are at risk of
thyroid dysfunction because of radiotherapy including the neck (i.e., thyroid
gland, or pituitary-hypothalamix axis). In view of patient car guidelines,
thyroid funcion will be assessed for clinical purposes. In addition, 400
control subjects treated with chemotherapy and 400 controls treated with
surgery (except brain surgery) from the same cohort who are not at risk for
thyroid dysfunction will be will be asked to participate in this study. For
them, the measurements of thyroid function are research-based.

Exclusion Criteria

diagnosis of childhood cancer with survival less than 5 years, age at diagnosis
>17 years or diagnosis while residing in foreign country. Patients who had a
thyroidectomy will not be eligible for measurement of thyroid function but will
be included in the cohort at risk or the control group, to obtain a complete
picture of the prevalence of thyroid problems

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Prevalence of hypothyroidism and hyperthyroidism:<br /><br>- plasma TSH and Free T4 concentrations<br /><br>- Anti-TPO (Anti-Thyroxine peroxidase) in survivors at risk, to determine the<br /><br>percentage of auto-immune hypothyroidism.<br /><br>material to be stored for determination of anti-TPO for all other survivors<br /><br>2) Presence of thyroid nodules<br /><br>- palpation of the neck<br /><br>3) presence of thyroid carciinoma<br /><br>- patient chart in addition to palpation of the neck</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Growth chart (information at 12 mnths, 2 yr and 4 yrs of age)<br /><br>Height and weight at start of treatment<br /><br>Parental heights<br /><br>Start puberty: age menarche (females), age Tanner M2 (from chart), age testis<br /><br>volume 4 cc (chart)<br /><br>Use of medication: oral antra-conceptives, anti-epileptics, GH, T4, cortisol,<br /><br>EE2, testosterone, DDAVP<br /><br>Previous endocrine deficiencies; if so, what year diagnosed, diagnosed based on<br /><br>functional tests (chart information)?<br /><br>Family history: thyroid diseases and family tree<br /><br>Physical examination:<br /><br>length (preferably stadiometer) en weight<br /><br>sitting-height<br /><br>Tanner stadia</p><br>