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

yasmeen magdi sholkamy

Status: Unknown

Conditions: Pediatric Disorder; Stem Cell Transplant Complications; Oral Disease; Graft-versus-host-disease

Study type: Observational

Funder types: Other

Identifiers

NCT03880214

developing chronic oral GVHD

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

250 participants in 1 patient group

stem cells transplanted pediatric patients

Description:

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