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Lipbiopsie bij Sjogrens Syndrome.


- candidate number8291
- NTR NumberNTR2446
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2010
- Secondary IDs10/011 MEC AMC
- Public TitleLipbiopsie bij Sjogrens Syndrome.
- Scientific TitleElucidating the pathogenesis of Sjögren’s syndrome: Analysis of lower lip biopsies.
- ACRONYMSjogrens lipbiopsie
- hypothesisTo gain more insight into the pathogenetic processes involved in Sjogrens Syndrome(SS) bij analyzing the infiltrate and structural changes in salivary glands of SS patients and compare these findings to those in other (aspecific) inflammatory and non-inflammatory salivary gland diseases.
- Healt Condition(s) or Problem(s) studiedAuto-immune diseases, Xerostomia, Sjogrens Syndrome
- Inclusion criteriaPatients undergoing lower lip biopsies for diagnostic purposes.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2010
- planned closingdate1-nov-2013
- Target number of participants200
- InterventionsIn all patients undergoing diagnostic lower lip biopsies, salivary gland tissue will be collected and processed using a standard protocol for formalin fixation to allow standard histological evaluation for diagnostic purposes. Samples will also be frozen in Tissue-Tek OCT compound for immunohistochemistry (IHC) or snap frozen for PCR, micro-array, T Cell Receptor (TCR) and B Cell Receptor (BCR) analysis, and protein expression analysis. Tissues will be analyzed using these techniques for exploratory analysis in relationship to the pathogenesis of SS.
- Primary outcomeObtained material will be used to elucidate primarily the B-cell pathogenesis of Sjogren's Syndrome. Using immunohistochemistry, RNS and protein analysis, the B-cel receptor (BCR), T-cell receptor (TCR), a B-cell stimulating cytokine (APRIL) and the interaction between different immune cell populations and cytokines will be studied
- Secondary outcomeN/A
- TimepointsOne, after lipbiopsy.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- PublicationsN/A
- Brief summaryCountry of recruitment: The Netherlands.
In all patients undergoing diagnostic lower lip biopsies, salivary gland tissue will be collected and studied.
- Main changes (audit trail)
- RECORD2-aug-2010 - 14-aug-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl