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NCT03602599 · ClinicalTrials.gov registry record
Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
A clinical trial of Graft-Versus-Host Disease, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Recruiting
- Registry status
- 500
- Enrollment target
- 1
- Study location
NCT03602599: Recruiting study of Graft-Versus-Host Disease, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT03602599 is a study of Graft-Versus-Host Disease that is actively recruiting participants, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 500 participants, above the 70-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (614% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03602599, a study of Graft-Versus-Host Disease, is actively recruiting participants, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: This study follows people who have had, or will soon have, a transplant using stem cells from another person. This is known as an allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (cGVHD) can happen after HSCT. cGVHD can cause mouth problems and more serious issues. Researchers want to study changes in the mouth that might indicate cGVHD. Objective: To identify cGVHD in the mouth and better understand the development, treatment, and progress of post-transplant changes in the mouth. Eligibility: Adults at least 18 years old who will soon undergo HSCT or have had one in the past 3 years Healthy adults at least 18 years old Design: All participants will have a screening visit and baseline visit. They will last 60-90 minutes. Over these two visits, participants will have: Medical and dental history Dental exam. Questions about their eating habits and general health Blood drawn through a needle in the arm Vital signs taken Pictures of their mouth and lips taken Questions about their oral health, including about pain, sensitivity, or dryness Saliva samples taken. Participants will spit into a sterile plastic tube. Swabs taken of the mouth and some of the saliva, plaque, and fluid from the spaces between teeth and gums. Participants may also have: A piece of skin taken (biopsy) from the inner lining of the cheeks A piece of skin taken (biopsy) from the lower lip Dental X-rays Urine pregnancy test Most participants will have at least 7 study visits over 3 years. They will meet with a dentist and repeat baseline tests.
Primary Outcome
Advance understanding of chronic graft versus host disease (cGVHD) pathophysiology and generate hypotheses for future cGVHD studies by tracking the longitudinal development of cGVHD in the oral cavity.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2037-03-03 |
What NCT03602599 shows while recruiting
NCT03602599 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 70-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (614% higher).
The record links to 1 condition, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 0 interventions.
NCT03602599 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03602599 about?
NCT03602599 is a clinical study titled "Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls". Background: This study follows people who have had, or will soon have, a transplant using stem cells from another person. This is known as an allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (cGVHD) can happen after HSCT. cGVHD can cause mouth problems and more seriou...
What is the current status of trial NCT03602599?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2018-11-15. Estimated completion is 2037-03-03.
What conditions does trial NCT03602599 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease.
Who is sponsoring clinical trial NCT03602599?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03602599 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03602599's enrollment target sits among peer trials
500 1st of 38 the highest of 38 other Graft-Versus-Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft-Versus-Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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