Clinical trial NCT03880214: Prevalence of Chronic Oral Graft Versus Host Disease Risk Factors in Pediatric Patients
Official title: Cross Sectional Study Estimating the Prevalence and Predicting Risk Factors for Developing Chronic Oral Graft Versus Host Disease in Pediatric Patients Subjected to Hematopoietic Stem Cells Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Disease
Graft-versus-host-disease
Stem Cell Transplant Complications
Pediatric Disorder
Keywords: oral GVHD
Pediatric
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. Every patient fulfilling inclusion criteria in 57357 pediatric hospital will be recruited consecutively in a period of 6 months starting from.....

Brief summary: our aim is estimating the Prevalence and predicting risk factors for developing chronic oral graft versus host disease in pediatric patients subjected to hematopoietic stem cells transplantation

Detailed description: The study will be held in Children's Cancer Hospital Egypt for pediatric patients who underwent bone marrow transplantation.

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.

Eligibility criteria: Inclusion Criteria:

1. Pediatric patients aged between 3 and 13 who underwent bone marrow transplantation at least 3 months ago.
2. Neoplastic or non- neoplastic diseases.
3. Patient receiving any protocol of GVHD prophylactic treatment.

Exclusion Criteria:

1. Patients who do not approve to join the study.
2. Patient receiving chemo or radiotherapy .

Primary outcomes:
measure: oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no)
timeFrame: 10 minutes
Secondary outcomes:
measure: salivary gland function
timeFrame: 10 minutes
measure: sclerotic disease assessed
timeFrame: 2 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer at Department of Oral Medicine and periodontology Cairo University
name: basma abd el alim
role: STUDY_CHAIR
References:
citation: (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.