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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

Tracking Information
First Submitted Date March 15, 2019
First Posted Date March 19, 2019
Last Update Posted Date March 20, 2019
Estimated Study Start Date April 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2019)
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) .
Original Primary Outcome Measures
 (submitted: March 15, 2019)
oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) [ Time Frame: 10 min ]
Clinical examination - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) .
Change History
Current Secondary Outcome Measures
 (submitted: March 19, 2019)
  • salivary gland function [ Time Frame: 10 minutes ]
    resting and stimulated saliva flow examination
  • sclerotic disease assessed [ Time Frame: 2 minutes ]
    inter incisional distance
Original Secondary Outcome Measures
 (submitted: March 15, 2019)
  • salivary gland function [ Time Frame: 10 min ]
    resting and stimulated saliva flow examination
  • sclerotic disease assessed [ Time Frame: 2 min ]
    inter incisional distance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Chronic Oral Graft Versus Host Disease Risk Factors in Pediatric Patients
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
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
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
Study Design Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.....
Condition
  • Oral Disease
  • Graft-versus-host-disease
  • Stem Cell Transplant Complications
  • Pediatric Disorder
Intervention Not Provided
Study Groups/Cohorts 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 15, 2019)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility 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 .
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 13 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: yasmeen magdi sholkamy, BDS 01069144373 yasmeen_sholkamy17@yahoo.com
Contact: wessam abd el moneim 01207033303 wesammhs@yahoo.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03880214
Other Study ID Numbers developing chronic oral GVHD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party yasmeen magdi sholkamy, Cairo University
Study Sponsor yasmeen magdi sholkamy
Collaborators Not Provided
Investigators
Study Chair: basma abd el alim Lecturer at Department of Oral Medicine and periodontology Cairo University
PRS Account Cairo University
Verification Date March 2019