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

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ClinicalTrials.gov Identifier: NCT03880214
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
yasmeen magdi sholkamy, Cairo University

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

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.


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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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



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) [ Time Frame: 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 [ Time Frame: 10 minutes ]
    resting and stimulated saliva flow examination

  2. sclerotic disease assessed [ Time Frame: 2 minutes ]
    inter incisional distance



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Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes 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.....
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880214


Contacts
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Contact: yasmeen magdi sholkamy, BDS 01069144373 yasmeen_sholkamy17@yahoo.com
Contact: wessam abd el moneim 01207033303 wesammhs@yahoo.com

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

Publications:
(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.

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Responsible Party: yasmeen magdi sholkamy, principle investigator , oral medicine department, Cairo University
ClinicalTrials.gov Identifier: NCT03880214     History of Changes
Other Study ID Numbers: developing chronic oral GVHD
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by yasmeen magdi sholkamy, Cairo University:
oral GVHD
Pediatric

Additional relevant MeSH terms:
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Graft vs Host Disease
Mouth Diseases
Immune System Diseases
Stomatognathic Diseases