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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged between 3 and 13 who underwent bone marrow transplantation at least 3 months ago.
- •Neoplastic or non- neoplastic diseases.
- •Patient receiving any protocol of GVHD prophylactic treatment.
排除标准
- •Patients who do not approve to join the study.
- •Patient receiving chemo or radiotherapy .
结局指标
主要结局
oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no)
时间窗: 10 minutes
Clinical examination - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) .
次要结局
- salivary gland function(10 minutes)
- sclerotic disease assessed(2 minutes)
研究者
yasmeen magdi sholkamy
principle investigator , oral medicine department
Cairo University