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NCT Number: NCT00898885

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

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.

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Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Immune System Diseases Mouth Diseases Oral Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • samples without epithelium or minor salivary glands

Treatment and study plan

oral biopsy

Procedure

oral mucosa and salivary gland biopsy after bone marrow transplantation

Other names: oral manifestations, graft-versus-host disease, bone marrow transplantation

Primary outcomes

  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.

    Time frame: during the survey data, and analysis of specimens

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: ORALGVHD

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
May 12, 2009
Registry last updated
May 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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