1) To study the late effects of 131-I treatment and TSH suppressive therapy as well as quality of life in patients with childhood-onset DTC. 2) To determine the presence of RET/PTC 1 and 3 translocations and BRAF mutations, and to investigate their…
ID
Source
Brief title
Condition
- Other condition
- Heart failures
- Thyroid gland disorders
Synonym
Health condition
kwaliteit van leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Incidence of late effects of 131-I treatment and TSH suppressive therapy.
2) Presence of somatic mutations and relation with clinical outcome.
Secondary outcome
Postoperative complications.
miRNA (-146b, -181b, -21, -221, -222) expression profile.
Incidence of family members with non-medullary thyroid carcinoma.
Background summary
Differentiated thyroid carcinoma (DTC) during childhood is an uncommon disease.
Children often present with a more advanced tumor stage and show higher
recurrence rates compared to adults. Nevertheless, the prognosis of
childhood-onset DTC is excellent. The treatment is comparable in children and
adults. However, data about long-term effects of 131-I treatment, long-term TSH
suppressive therapy and quality of life in pediatric DTC patients are limited.
Furthermore, it is not known if there is a relation between the presence of
somatic mutations like BRAF and RET/PTC and the clinical course in pediatric
DTC patients outside the Chernobyl region. More knowledge on treatment related
damage might result in recommendations regarding childhood tailored therapy.
Knowledge about the predictive value of the presence of somatic mutations in
thyroid tumors could support the choice of more patient tailored treatment.
Study objective
1) To study the late effects of 131-I treatment and TSH suppressive therapy as
well as quality of life in patients with childhood-onset DTC.
2) To determine the presence of RET/PTC 1 and 3 translocations and BRAF
mutations, and to investigate their relationship with clinical outcome.
Study design
1. Multicenter cross-sectional study.
2. Follow-up study of the cross-sectional study
Study burden and risks
Burden: 5-year survivors of pediatric DTC will undergo physical examination,
blood sampling and will be asked to fill out a general health questionnaire. In
addition, in patients aged >=18 years echocardiography, bone mineral density
measurement, an electrocardiogram (ECG) and in men semen analysis will be
performed at the day of the outpatient clinic visit. Also, these patients will
be asked to complete quality of life questionnaires and to wear an (ambulatory)
ECG device for 24 hours performing normal daily activities.
Risks: during BMD measurement, patients are exposed to an effective radiation
dose below 0.1 mSv. According to the ICRP-62, this study falls into the lowest
risk category (I-trivial risk). Therefore, this study is without risk for
participants.
Benefit: 5-year survivors will be examined for possible late effects of
treatment and will be informed about their health status.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Differentiated thyroid carcinoma diagnosed between 1970 and 2013 at age <= 18 years and treated in the Netherlands.
Exclusion criteria
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').
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL40572.042.12 |
| OMON | NL-OMON28040 |