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
  Purpose

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 Intervention
Graft-Versus-Host Disease
Procedure: oral biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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


Enrollment: 41
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bone Marrow Transplantation Procedure: oral biopsy
oral mucosa and salivary gland biopsy after bone marrow transplantation
Other Names:
  • oral manifestations
  • graft-versus-host disease
  • bone marrow transplantation

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • samples without epithelium or minor salivary glands
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00898885

Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Marina HG Magalhães, DMD, PhD University of Sao Paulo - Brazil
  More Information

No publications provided

Responsible Party: Paulo Sérgio da Silva Santos, School of Dentistry - Oral Pathology
ClinicalTrials.gov Identifier: NCT00898885     History of Changes
Other Study ID Numbers: OPPSSS1
Study First Received: May 11, 2009
Last Updated: May 11, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
oral manifestations
bone marrow transplantation
adverse effects

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014