Analysis of the Clinical and Histological Correlation of Oral Graft-Versus-Host-Disease (GVHD) (ORALGVHD)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa|
- 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 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
samples of oral mucosa and minor salivary glands stained with hematoxylin and eosin for visualization of the layers in optical microscope
|Study Start Date:||January 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|Bone Marrow Transplantation||
Procedure: oral biopsy
oral mucosa and salivary gland biopsy after bone marrow transplantation
Methods: For this study we analyzed histological samples of oral mucosa of 10 patients with clinical diagnosis of GVHD, which have areas of epithelium, and salivary gland. The histopathological aspects were observed by the author of this work and his advisor, so blinded by applying the criteria for Horn and the Consensus. We consistency between the two classifications obtained and histological correlation with the clinical classification of GVHD (Akpek, 2001) and the curve of survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898885
|Study Chair:||Marina HG Magalhães, DMD, PhD||University of Sao Paulo - Brazil|