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Associatie tussen de ziekte van Graves en thymushyperplasie.


- candidate number6785
- NTR NumberNTR2135
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-dec-2009
- Secondary IDsNL22657.078.08 CCMO Erasmus MC Rotterdam
- Public TitleAssociatie tussen de ziekte van Graves en thymushyperplasie.
- Scientific TitleAssociation of Graves' disease and thymic hyperplasia.
- ACRONYM
- hypothesisAntibodies to the TSH receptor which are produces in Graves' disease can enhance T cell development.
- Healt Condition(s) or Problem(s) studiedImmunodefiencies
- Inclusion criteria1. Graves' disease;
2. 18-40 years of age.
- Exclusion criteria1. Use of corticosteroids last three months;
2. Infections during last three months;
3. Thymectomy;
4. Pregnancy;
5. Alcohol abuse.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-jul-2009
- planned closingdate1-jan-2011
- Target number of participants30
- InterventionsN/A
- Primary outcomeOccurrence of thymic hyperplasia in patients with Graves' disease, presence of thymic hyperplasia will be analysed with I123 scan 20min and 24hours after intake of I123.
Outcomes will be compared with a database of healthy people, which is already present.
- Secondary outcomeSecondary endpoints consist of a change in thymic output, peripheral cell numbers or ratio’s of peripheral T cell subpopulations in comparison to healthy controls.
- TimepointsT0 blood sample;
T1 scan 20 min after radioactive iodine;
T2 scan 24h after radioactive iodine.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Kim Weerd, van der
- CONTACT for SCIENTIFIC QUERIES Kim Weerd, van der
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryGraves' disease is associated with thymic hyperplasia. Since it is known that the TSH receptor is also present in the thymus, stimulating antibodies against the TSH receptor could play a role in thymic hyperplasia. The aim of this study is to investigate how often thymic hyperplasia is present in Graves' disease. Moreover we will investigate if thymic hyperplasia in Graves' disease is caused by stimulation of T cell development in the thymus. 30 patients with Graves' disease who will be treated with radioactive iodine therapy will be recruited on the nuclear medicine department. After the radioactive iodine scan according to the regular treatment, an extra scan will be made from the thymus. Moreover blood samples of these patients will be taken to analyse the t cell pool.
- Main changes (audit trail)
- RECORD4-dec-2009 - 18-dec-2009


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