Analysis of the Clinical and Histological Correlation of Oral Graft-Versus-Host-Disease (GVHD) (ORALGVHD)
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|ClinicalTrials.gov Identifier: NCT00898885|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 12, 2009
Introduction: Graft-versus-host-disease (GVHD) is the major cause of morbidity and mortality in patients submitted to the Bone Marrow Transplantation (BMT). The oral manifestations can be very debilitating and interfere in the results of medical therapy, leading to systemic complications, committing the prognosis and quality of life of the patient.
The early diagnosis can be done through biopsies of oral mucosa with or without apparent injury clinic. The association between the clinical and histopathological tables of GVHD, especially through the use of recent consensus established in these areas, can bring new benefits to physicians.
Objective: This study aims to apply and compare the two classifications histological to GVHD, Horn (1995) and Consensus (2006) in specimens obtained from clinical oral lesions suggestive of GVHD; correlate them with clinical classification according Akpek (2001) and with the survival of the patients.
|Condition or disease||Intervention/treatment|
|Graft-Versus-Host Disease||Procedure: oral biopsy|
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||April 2009|
|Bone Marrow Transplantation||
Procedure: oral biopsy
oral mucosa and salivary gland biopsy after bone marrow transplantation
- The histological classification according Horn showed that in most cases there was presence of GVHD with low degrees of severity; Already classification of the Consensus showed that there were in full presence of GVHD of moderate degree. [ Time Frame: during the survey data, and analysis of specimens ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898885
|Study Chair:||Marina HG Magalhães, DMD, PhD||University of Sao Paulo - Brazil|