No registrations found.
ID
Source
Health condition
Differentiated thyroid carcinoma, thyroid cancer, late effects, child
In Dutch:
Gedifferentieerd schildkliercarcinoom, schildklierkanker, late effecten, kind
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the incidence of late effects of 131-I treatment and TSH suppressive therapy including quality of life.
Secondary outcome
Secondary outcomes are the presence of somatic mutations and relation with clinical outcome, miRNA (-146b, -181b, -21, -221, -222) expression profile, and incidence of family members with non-medullary thyroid carcinoma.
Background summary
Background of the study:
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.
Objective of the study:
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. In addition, the postoperative complications and the presence of somatic mutations and their relationship with clinical outcome will be assessed.
Study design:
Multicenter cross-sectional study.
Study population:
All patients with childhood-onset DTC (age <19 years) diagnosed between 1970 and 2013 and treated in the Netherlands. About 150 patients are expected to be included in this study.
Primary study parameters:
The incidence of late effects of 131-I treatment and TSH suppressive therapy.
Secundary study parameters:
Presence of somatic mutations and relation with clinical outcome.
miRNA (-146b, -181b, -21, -221, -222) expression profile.
Incidence of family members with non-medullary thyroid carcinoma.
Study objective
Differentiated thyroid carcinoma (DTC) is rare during childhood. Children often present with a more advanced tumor stage compared to adults. Nevertheless, the prognosis is excellent. Data about long-term effects of treatment in pediatric DTC patients are limited. It is not known if there is a relation between the presence of somatic mutations 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 design
N/A
Intervention
N/A
Department of Endocrinology, AA31<br>
P.O. Box 30.001
M.S. Klein Hesselink
Groningen 9700 RB
The Netherlands
+31 (0)50 3613962
ms.kleinhesselink@umcg.nl
Department of Endocrinology, AA31<br>
P.O. Box 30.001
M.S. Klein Hesselink
Groningen 9700 RB
The Netherlands
+31 (0)50 3613962
ms.kleinhesselink@umcg.nl
Inclusion criteria
Differentiated thyroid carcinoma diagnosed between 1970 and 2013 at age <19 years and treated in the Netherlands.
Exclusion criteria
No exclusion criteria have been established for the study in its entirety. However, for evaluation of late effects including quality of life the following exclusion criteria are applicable:
1. DTC as a second malignancy;
2. <5 years since diagnosis;
3. Thyroid hormone withdrawal or rhTSH <3 months before evaluation;
4. There are additional exclusion criteria for specific parts of the study.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3280 |
| NTR-old | NTR3448 |
| CCMO | NL40572.042.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON44899 |