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Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
NCT03602599 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03602599
The ClinicalTrials.gov registry entry for NCT03602599 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Graft Versus Host Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03602599 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT03602599?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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