Oral DiseaseNCT03880214
Prevalence of Chronic Oral Graft Versus Host Disease Risk Factors in Pediatric Patients
An observational study of Oral Disease and Graft-versus-host-disease, run by yasmeen magdi sholkamy.
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 Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Oral Disease, Graft-versus-host-disease, Stem Cell Transplant Complications
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- Child
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.....
Who may be able to join
- Pediatric patients aged between 3 and 13 who underwent bone marrow transplantation at least 3 months ago.
- Neoplastic or non- neoplastic diseases.
- Patient receiving any protocol of GVHD prophylactic treatment.
Who cannot join
- Patients who do not approve to join the study.
- Patient receiving chemo or radiotherapy .
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Conditions
- Oral Disease, Graft-versus-host-disease, Stem Cell Transplant Complications, Pediatric Disorder
- Keywords
- oral GVHD, Pediatric
- Medical subject headings
- Mouth Diseases, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 10 minutes
Secondary outcomes (2)
salivary gland function
resting and stimulated saliva flow examination
Measured: 10 minutes
sclerotic disease assessed
inter incisional distance
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yasmeen magdi sholkamy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yasmeen magdi sholkamy, Cairo University
- Investigators
- basma abd el alim, Study chair, Lecturer at Department of Oral Medicine and periodontology Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880214
- Sponsor's protocol ID
- developing chronic oral GVHD
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23607797
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03880214
- Acronym / sponsor ID
- developing chronic oral GVHD
- Conditions
- Oral Disease, Graft-versus-host-disease, Stem Cell Transplant Complications, Pediatric Disorder
- Keywords
- oral GVHD, Pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- yasmeen magdi sholkamyUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Age groups
- Child
- 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.....
Key inclusion criteria (3 listed)
- Pediatric patients aged between 3 and 13 who underwent bone marrow transplantation at least 3 months ago.
- Neoplastic or non- neoplastic diseases.
- Patient receiving any protocol of GVHD prophylactic treatment.
Key exclusion criteria (2 listed)
- Patients who do not approve to join the study.
- Patient receiving chemo or radiotherapy .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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) .
2 secondary outcomes
salivary gland function
Time frame: 10 minutes
sclerotic disease assessed
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Background: PubMed 23607797Muller 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
basma abd el alim study chair
Lecturer at Department of Oral Medicine and periodontology Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Disease and Graft-versus-host-disease, run by yasmeen magdi sholkamy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yasmeen magdi sholkamy, BDS (01069144373, yasmeen_sholkamy17@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.