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

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

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.....

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no)	Clinical examination - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) .	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary gland function	resting and stimulated saliva flow examination	10 minutes
sclerotic disease assessed	inter incisional distance	2 minutes

Collaborators and Investigators

• Sponsor: yasmeen magdi sholkamy
• Investigators: Study Chair: basma abd el alim, Lecturer at Department of Oral Medicine and periodontology Cairo University

Publications and helpful links

General Publications

• Muller L, van Waes H, Langerweger C, Molinari L, Saurenmann RK. Maximal mouth opening capacity: percentiles for healthy children 4-17 years of age. Pediatr Rheumatol Online J. 2013 Apr 22;11:17. doi: 10.1186/1546-0096-11-17. eCollection 2013.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pediatric; oral GVHD
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Mouth Diseases; Graft vs Host Disease
• Other Study ID Numbers: developing chronic oral GVHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No