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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00898885
• Collaborator: (none)
• Enrollment: 41
• Duration (Months): 15

Study Details

Study Description

Brief Summary

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	Phase
Graft-Versus-Host Disease	Procedure: oral biopsy

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 41 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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. [during the survey data, and analysis of specimens]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• University of Sao Paulo

Investigators

• Study Chair: Marina HG Magalhães, DMD, PhD, University of Sao Paulo - Brazil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00898885
• Other Study ID Numbers: OPPSSS1
• First Posted: May 12, 2009
• Last Update Posted: May 12, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: oral manifestations; bone marrow transplantation; adverse effects
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of May 12, 2009