Graft-Versus-Host DiseaseORALGVHDNCT00898885
Analysis of the Clinical and Histological Correlation of Oral Graft-Versus-Host-Disease (GVHD)
An observational study of Graft-Versus-Host Disease, run by University of Sao Paulo.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- oral biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients underwent bone marrow transplantation with clinical signs of oral Graft-versus-host Disease
Who may be able to join
- all patients with clinical signs of oral GVHD that underwent oral biopsy
Who cannot join
- samples without epithelium or minor salivary glands
About this study
Official title: Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa
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.
Read the detailed 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.
- Conditions
- Graft-Versus-Host Disease
- Being tested
- oral biopsy
- Keywords
- oral manifestations, bone marrow transplantation, adverse effects
- Medical subject headings
- Graft vs Host Disease, Oral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral biopsyProcedure or surgery
Also called oral manifestations, graft-versus-host disease, bone marrow transplantation
oral mucosa and salivary gland biopsy after bone marrow transplantation
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Transplantation | Not described Receives: Procedure: oral biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the survey data, and analysis of specimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Marina HG Magalhães, DMD, PhD, Study chair, University of Sao Paulo - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898885
- Sponsor's protocol ID
- OPPSSS1
- Acronym
- ORALGVHD
- Status last verified
- May 2009
- First submitted
- 11 May 2009
- Last updated
- 12 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa
- ClinicalTrials.gov ID
- NCT00898885
- Acronym / sponsor ID
- ORALGVHD / OPPSSS1
- Conditions
- Graft-Versus-Host Disease
- Keywords
- oral manifestations, bone marrow transplantation, adverse effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Transplantation | – | Procedure: oral biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients underwent bone marrow transplantation with clinical signs of oral Graft-versus-host Disease
Key inclusion criteria (1 listed)
- all patients with clinical signs of oral GVHD that underwent oral biopsy
Key exclusion criteria (1 listed)
- samples without epithelium or minor salivary glands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral biopsyAlso: oral manifestations, graft-versus-host disease, bone marrow transplantationoral mucosa and salivary gland biopsy after bone marrow transplantation | Procedure or surgery | Bone Marrow Transplantation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina HG Magalhães, DMD, PhD study chair
University of Sao Paulo - Brazil
Questions about this trial
What is this clinical trial studying?
An observational study of Graft-Versus-Host Disease, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2009.