Prevalence of Chronic Oral Graft Versus Host Disease Risk Factors in Pediatric Patients
NCT ID: NCT03880214
Last Updated: 2019-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
250 participants
OBSERVATIONAL
2019-04-30
2019-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
NCT03602599
Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
NCT00092235
Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease
NCT02194439
Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation
NCT07235501
Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA
NCT05315882
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
this study describes oral conditions, detect possible oral pathological manifestations and evaluate their prevalence as well as correlating it to assumed risk factor as age, sex, type of the transplant , previous acute attack of graft versus host disease and other organ involvement . A standardized Transplant Database Questionnaire will be completed Clinical examination will be performed then findings will be recorded for oral mucosal lesions , salivary flow rate in milliliter , mouth opening in milliimeter.
Sample size estimation :
The aim of this study is to screen pediatric patients at least three months after they undergo allogeneic hematopoietic stem cells transplantation to detect any risk factors for developing oral manifestations of chronic graft versus host disease during this period. Every patient fulfilling inclusion criteria in the hospital will be recruited consecutively in a period of six months starting from April 2019.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
stem cells transplanted pediatric patients
screen pediatric patients at least 3 months after they undergo allogeneic hematopoietic stem cells transplantation to detect any risk factors for developing oral manifestations of chronic graft -versus-host disease during this period
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Neoplastic or non- neoplastic diseases.
3. Patient receiving any protocol of GVHD prophylactic treatment.
Exclusion Criteria
2. Patient receiving chemo or radiotherapy .
3 Years
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
yasmeen magdi sholkamy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
yasmeen magdi sholkamy
principle investigator , oral medicine department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
basma abd el alim
Role: STUDY_CHAIR
Lecturer at Department of Oral Medicine and periodontology Cairo University
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
(Study Result )Hull K, Oral Long-Term Complications of AllogeneicHematopoietic Stem Cell Transplantation. 2009, Doctorate degree, University of Sydney, Australia (Study Result )Müller I, van Waes H, Langerweger C, Luciano C, Rotraud K Saurenmann.Maximal mouth opening capacity: percentiles forhealthy children 4-17 years of age.Pediatric Rheumatology 2013; 11:17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
developing chronic oral GVHD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.