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

Stem Cell Transplant Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03880214
• Other study ID #: developing chronic oral GVHD
• Status: Not yet recruiting
• Start date: April 2019
• Est. completion date: October 2019

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: yasmeen magdi sholkamy, BDS
• Phone: 01069144373
• Email: yasmeen_sholkamy17[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Gender: All
• Age group: 3 Years to 13 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-host-disease
• Mouth Diseases
• Oral Disease
• Pediatric Disorder
• Stem Cell Transplant Complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
yasmeen magdi sholkamy

References & Publications (1)

(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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	salivary gland function	resting and stimulated saliva flow examination	10 minutes
Secondary	sclerotic disease assessed	inter incisional distance	2 minutes