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

NCT ID: NCT00898885

Last Updated: 2009-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Graft-Versus-Host Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bone Marrow Transplantation

oral biopsy

Intervention Type PROCEDURE

oral mucosa and salivary gland biopsy after bone marrow transplantation

Interventions

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oral biopsy

oral mucosa and salivary gland biopsy after bone marrow transplantation

Intervention Type PROCEDURE

Other Intervention Names

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oral manifestations graft-versus-host disease bone marrow transplantation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* samples without epithelium or minor salivary glands
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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School of Dentistry - Oral Pathology

Principal Investigators

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Marina HG Magalhães, DMD, PhD

Role: STUDY_CHAIR

University of Sao Paulo - Brazil

Other Identifiers

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OPPSSS1

Identifier Type: -

Identifier Source: org_study_id

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