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Differentiated thyroid carcinoma in children: Late effects of treatment and pathophysiological background in the Netherlands.


- candidate number12401
- NTR NumberNTR3448
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-mei-2012
- Secondary IDsNL40572.042.12 CCMO
- Public TitleDifferentiated thyroid carcinoma in children: Late effects of treatment and pathophysiological background in the Netherlands.
- Scientific TitleDifferentiated thyroid carcinoma in children: Late effects of treatment and pathophysiological background in the Netherlands.
- ACRONYM
- hypothesisDifferentiated 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.
- Healt Condition(s) or Problem(s) studiedDifferentiated thyroid carcinoma, Children, Late effects
- Inclusion criteriaDifferentiated thyroid carcinoma diagnosed between 1970 and 2011 at age <19 years and treated in the Netherlands.
- Exclusion criteriaNo 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. Not domiciled in the Netherlands;
4. Thyroid hormone withdrawal or rhTSH <3 months before evaluation;
5. There are additional exclusion criteria for specific parts of the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2012
- planned closingdate1-mrt-2014
- Target number of participants150
- InterventionsN/A
- Primary outcomeThe primary endpoint is the incidence of late effects of 131-I treatment and TSH suppressive therapy including quality of life.
- Secondary outcomeSecondary 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.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M.S. Klein Hesselink
- CONTACT for SCIENTIFIC QUERIESDrs. M.S. Klein Hesselink
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Kinderen Kankervrij, Nederland
- PublicationsN/A
- Brief summaryBackground 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 2011 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.
- Main changes (audit trail)Inclusion criteria: Differentiated thyroid carcinoma diagnosed between 1970 and 2013 at age <19 years and treated in the Netherlands. Exclusion criteria: 3. Not domiciled in the Netherlands expired. Planned closingdate: 1-aug-2014 instead of 1-mrt-2014. Brief summary: 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.
- RECORD22-mei-2012 - 7-jun-2013


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