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

Sponsor
yasmeen magdi sholkamy (Other)
Overall Status
Unknown status
CT.gov ID
NCT03880214
Collaborator
(none)
250
Enrollment
6
Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    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
    Anticipated Study Start Date :
    Apr 1, 2019
    Anticipated Primary Completion Date :
    Oct 1, 2019
    Anticipated Study Completion Date :
    Oct 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) [10 minutes]

      Clinical examination - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) .

    Secondary Outcome Measures

    1. salivary gland function [10 minutes]

      resting and stimulated saliva flow examination

    2. sclerotic disease assessed [2 minutes]

      inter incisional distance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 13 Years
    Sexes Eligible for Study:
    All
    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 .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • yasmeen magdi sholkamy

    Investigators

    • Study Chair: basma abd el alim, Lecturer at Department of Oral Medicine and periodontology Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    yasmeen magdi sholkamy, principle investigator , oral medicine department, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03880214
    Other Study ID Numbers:
    • developing chronic oral GVHD
    First Posted:
    Mar 19, 2019
    Last Update Posted:
    Mar 20, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by yasmeen magdi sholkamy, principle investigator , oral medicine department, Cairo University
    oral GVHD
    Pediatric
    Additional relevant MeSH terms:
    Mouth Diseases
    Graft vs Host Disease

    Study Results

    No Results Posted as of Mar 20, 2019