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

NCT00898885 | Completed DMC

• 1 other identifier: OPPSSS1
• Study Type: observational
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Graft-Versus-Host Disease

Keywords

oral manifestations; bone marrow transplantation; adverse effects

Outcome Measures

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.

  during the survey data, and analysis of specimens

Study Arms (1)

Bone Marrow Transplantation

Procedure: oral biopsy

Interventions

oral biopsy PROCEDURE

oral mucosa and salivary gland biopsy after bone marrow transplantation

Also known as: oral manifestations, graft-versus-host disease, bone marrow transplantation

Bone Marrow Transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• samples without epithelium or minor salivary glands

Sponsors & Collaborators

• University of Sao Paulo: lead

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

MeSH Terms

Conditions

Graft vs Host Disease; Oral Manifestations

Interventions

Biopsy; Bone Marrow Transplantation

Condition Hierarchy (Ancestors)

Immune System Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation

Study Officials

• Marina HG Magalhães, DMD, PhD

  University of Sao Paulo - Brazil

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 12, 2009
• Study Start: January 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: April 1, 2009
• Last Updated: May 12, 2009

Record last verified: 2009-05