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UnknownNCT03880214

Prevalence of Chronic Oral Graft Versus Host Disease Risk Factors in Pediatric Patients

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

Status
Unknown
Phase
Study type
Observational
Enrollment
250 (estimated)
Sponsor
yasmeen magdi sholkamy · Academic / Other
Sex
All
Age
3 Years – 13 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2019-04-01
Primary completion
2019-10-01
Completion
2019-10-01
First posted
2019-03-19
Last updated
2019-03-20

Source: ClinicalTrials.gov record NCT03880214. Inclusion in this directory is not an endorsement.