An observational study in Graft-Versus-Host Disease, sponsored by University of Sao Paulo. Completed. Per ClinicalTrials.gov, last updated 2009-05-12.
Sponsored by University of Sao Paulo · Observational
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.
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.
815 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 41 is below the median of 82 across 104 observational studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients underwent bone marrow transplantation with clinical signs of oral Graft-versus-host Disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Procedure: oral biopsy
oral mucosa and salivary gland biopsy after bone marrow transplantation
Also known as: oral manifestations, graft-versus-host disease, bone marrow transplantation
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
No study locations are listed for this record.
The record gives a start of Jan 2008, a primary completion of Oct 2008 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.