Last reviewed · How we verify
NCT03602599
Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
trial in Graft Versus Host Disease in 500 participants. Currently enrolling.
3 March 2037
Quick facts
| Lead sponsor | National Institute of Dental and Craniofacial Research (NIDCR) |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 15 November 2018 |
| Primary completion | 3 March 2037 |
| Estimated completion | 3 March 2037 |
| Sites | 1 location across United States |
Conditions studied
- Graft Versus Host Disease — all drugs for Graft Versus Host Disease →
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Who can join
Adults 18 to 100, any sex, with Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Salivary ZG16B expression loss follows exocrine gland dysfunction related to oral chronic graft-versus-host disease.
Costa-da-Silva AC, Aure MH, Dodge J, Martin D, et al · · 2022 · cited 30× · PMID 35005541 · DOI 10.1016/j.isci.2021.103592 -
Atto 465 Derivative Is a Nuclear Stain with Unique Excitation and Emission Spectra Useful for Multiplex Immunofluorescence Histochemistry.
Dodge JT, Doyle AD, Costa-da-Silva AC, Hogden CT, et al · · 2022 · cited 2× · PMID 34994225 · DOI 10.1369/00221554211064942 -
Oral Health Characteristics 2 Years following Allogeneic Cell Transplant.
Leinbach LI, Boroumand S, Masuch LR, Nguyen JT, et al · · 2025 · cited 1× · PMID 40353516 · DOI 10.1177/00220345251329351
Verify or expand the search:
- PubMed search for NCT03602599
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Graft Versus Host Disease
Currently open trials in the same condition.
- NCT07356245 — Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma · Phase 2 · recruiting
- NCT07006506 — A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant · Phase 2 · recruiting
- NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting
- NCT06705062 — Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment · Phase 3 · recruiting
- NCT06252870 — Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-trans · Phase 2 · recruiting
Other National Institute of Dental and Craniofacial Research (NIDCR) trials
Trials by the same sponsor.
- NCT07281456 — Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease · Phase 2 · recruiting
- NCT05735015 — PTH-independent Effects of Encaleret · Phase 2 · completed
- NCT05509595 — Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia · Phase 2 · completed
- NCT05419050 — Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia · Phase 2 · completed
- NCT04496960 — Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03602599 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Dental and Craniofacial Research (NIDCR)
- Last refreshed: 14 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03602599.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing