Analysis of the Clinical and Histological Correlation of Oral Graft-Versus-Host-Disease (GVHD) (ORALGVHD)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00898885
First received: May 11, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 11, 2009
May 11, 2009
January 2008
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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Analysis of the Clinical and Histological Correlation of Oral Graft-Versus-Host-Disease (GVHD)
Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

samples of oral mucosa and minor salivary glands stained with hematoxylin and eosin for visualization of the layers in optical microscope

Probability Sample

patients underwent bone marrow transplantation with clinical signs of oral Graft-versus-host Disease

Graft-Versus-Host Disease
Procedure: oral biopsy
oral mucosa and salivary gland biopsy after bone marrow transplantation
Other Names:
  • oral manifestations
  • graft-versus-host disease
  • bone marrow transplantation
Bone Marrow Transplantation
Intervention: Procedure: oral biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
April 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients with clinical signs of oral GVHD that underwent oral biopsy

Exclusion Criteria:

  • samples without epithelium or minor salivary glands
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00898885
OPPSSS1
Yes
Paulo Sérgio da Silva Santos, School of Dentistry - Oral Pathology
University of Sao Paulo
Not Provided
Study Chair: Marina HG Magalhães, DMD, PhD University of Sao Paulo - Brazil
University of Sao Paulo
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP