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

Graft-Versus-Host Disease Clinical Trial

— ORALGVHD  

Official title:

Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898885
• Other study ID #: OPPSSS1
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: May 11, 2009
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• samples without epithelium or minor salivary glands

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease

Intervention

Procedure:
• oral biopsy
oral mucosa and salivary gland biopsy after bone marrow transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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