Differentiated thyroid carcinoma in children: Late effects of treatment and pathophysiological background in the Netherlands
- Conditions
- kwaliteit van levenDifferentiated thyroid carcinomathyroid cancer1001928010043739
- Registration Number
- NL-OMON44899
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
Differentiated thyroid carcinoma diagnosed between 1970 and 2013 at age <= 18 years and treated in the Netherlands.
Not applicable for the study in its entirety because analysis of somatic mutations will be performed in all patients. Late effects are defined as effects occurring >= 5 years after diagnosis. So, evaluation of late effects will only be performed in 5-year survivors. ;Therefore, exclusion criteria are applicable for the following parts of the study:
A. Evaluation late effects including quality of life:
- <5 years since diagnosis
- DTC as a second malignancy
- Thyroid hormone withdrawal or rhTSH <3 months before evaluation;B. In addition to A, for semen analysis:
- Use of drugs that interact with semen quality
- Use of anabolic steroids
- Fever (body temperature >38°C) in the three months before semen analysis;C. In addition to A, for evaluation quality of life:
- Not fluent in Dutch;An exhaustive account based on the inclusion- and exclusioncriteria is provided below 'Aanvullende opmerkingen' ('Additional remarks').
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Incidence of late effects of 131-I treatment and TSH suppressive therapy.<br /><br>2) Presence of somatic mutations and relation with clinical outcome.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Postoperative complications.<br /><br>miRNA (-146b, -181b, -21, -221, -222) expression profile.<br /><br>Incidence of family members with non-medullary thyroid carcinoma.</p><br>