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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

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 - SKION LATER Q2008 - Thyroid function

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47586
Enrollment
2281
Registered
2015-01-23
Start date
2016-05-04
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

thyroid dysfunction

Interventions

None listed

Sponsors

Stichting Kinderoncologie Nederland
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)