Graft Versus Host DiseaseNCT03602599
Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
An observational study of Graft Versus Host Disease, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Graft Versus Host Disease
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 22 May 2026
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects in Cohort NT and Cohort PT will be scheduled to undergo allogeneic hematopoietic stem cell transplant at the NIH (Cohort NT) or have already undergone allogeneic HSCT at the NIH or another institution (Cohort PT) and are within 3 years of most recent bone marrow transplant. Subjects in Cohort HL and Cohort HS will be healthy volunteers and may potentially be age- and/or sex-matched with a transplant patient participant. All subjects will be at least 18 years of age.
Who may be able to join
- Subjects in Cohort NT and Cohort PT must satisfy all of the following criteria in order to participate in the study:
- Scheduled to undergo allogeneic HSCT at the NIH (Cohort NT) or have already undergone allogeneic HSCT at the NIH or another institution (Cohort PT) and are within 3 years of most recent bone marrow transplant
- Willing to participate in protocol evaluations including saliva collection, oral swab collection, and completion of patient-reported outcome (PRO) forms
- Willing to return to the NIH Dental Clinic for scheduled evaluations
- Be at least 18 years of age at screening
- Be able to understand and provide written informed consent
Show all 12Show fewer
- Subjects in Cohort HL and Cohort HS must satisfy all of the following criteria in order to participate in the study:
- Willing to undergo oral exam and participate in Visit 1 protocol evaluations including saliva collection, oral swab collection and oral biopsies.
- Be at least 18 years of age at screening
- Be able to understand and provide written informed consent
- Potentially be age- and/or sex-matched with a transplant patient
- Subjects in Cohort HL must additionally be willing and able to return to the NIH Dental Clinic for scheduled visits across 1 year and participate in evaluations including saliva collection, oral swab collection, and completion of PRO forms
Who cannot join
- Subjects in any Cohort will be excluded if they are pregnant, as pregnancy can have a confounding effect on the oral microbiome
- Subjects in Cohort NT may not participate in the study if, in the opinion of the NIH transplant team, participation in the protocol would not be safe or in the subject s best interest
- Subjects in Cohort PT. There are no additional exclusion criteria for subjects in this cohort.
- Subjects in Cohorts HL and Cohort HS may not participate in the study if they meet either of the following criteria:
- Have any acute oral mucosal or dental infection requiring multiple dental appointments or specialist referral for treatment; uncontrolled chronic disease; active systemic illness; are currently undergoing orthodontic treatment; history of frequent opportunistic infection; autoimmune disease; immunosuppressive medications; or prior organ, bone marrow, or peripheral blood stem cell transplant
- Are taking medications or are on other ongoing therapies that have a known or suspected major impact on the oral microbiome
- Subjects in Cohort HL additionally may not participate if they are planning to become pregnant within the next year or refuse to have oral biopsies.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Natural History of 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 serious issues. Researchers want to study changes in the mouth that might indicate cGVHD.
Read more
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.
Read the detailed description
Background:
- Chronic graft-versus-host disease (cGVHD) is a multi-organ severe alloimmune and - autoimmune disorder that occurs after allogeneic hematopoietic stem cell transplantation (HSCT). It is characterized by immune dysregulation, immunodeficiency, impaired organ function, and decreased survival.
- Manifestations of cGVHD in the oral cavity are observed in 45-85% of cGVHD patients and include 3 components: limitation of mouth opening, oral mucosal changes (lichenoid lesions, ulceration) and salivary gland changes.
- There is an urgent need for new tools to diagnose and treat oral cGVHD. To develop targeted therapies and non-invasive methods for serial screening, an improved understanding of the clinical course and underlying mechanisms of oral cGVHD are required.
Objectives:
- Advance understanding of cGVHD pathophysiology and generate hypotheses for future cGVHD studies by tracking the longitudinal development of cGVHD in the oral cavity and transplant-related changes in the oral microenvironment.
- Leverage knowledge about the impact of transplant on the oral cavity to develop better protocols for supportive dental care, to refine clinical definitions and classifications of oral cGVHD, and to test and improve criteria and tools for clinical trials.
- Include healthy volunteer cohorts both as a direct control group for HSCT patients, and to characterize measures of interest that were not previously defined in the normal oral cavity.
Eligibility:
- Patients who are scheduled to undergo allogeneic HSCT at the National Institutes of Health (NIH) or who have already undergone allogeneic HSCT at the NIH or elsewhere.
- Healthy individuals who have not undergone transplant and are willing to undergo oral exam and sample collection will be included in a control group.
- All study subjects, including patients and healthy individuals, must be able to provide written informed consent and be willing to return to the NIH Dental Clinic for scheduled evaluations.
Design:
- This is a single site, observational study with four cohorts. There are 2 transplant cohorts: the New Transplant Cohort ("Cohort NT"; approximate n=300) consists of patients who are scheduled to undergo allogeneic HSCT (under another protocol at the NIH) and the Prior Transplant Cohort ("Cohort PT"; approximate n=100) consists of patients who have already undergone allogeneic HSCT. These Cohorts will have up to 7 regularly scheduled visits across 3 years, along with a variable number of acute-episode visits. Subjects enrolled as NT or PT, who require a subsequent transplant are eligible to be either enrolled or re-enrolled into the PT cohort to be followed for the 7 visits in 3 years. Additionally, subjects will have the opportunity to participate in optional annual follow-up visits in years 4-10 post transplant.
- The other 2 Cohorts include healthy volunteers: the Healthy-controls Longitudinal (HL) Cohort ("Cohort HL"; approximate n=20) includes subjects who will participate in up to 4 study visits across 1 year, and the Healthy-controls Short-term (HS) Cohort ("Cohort HS"; approximate n=80) will participate in a single baseline visit.
- Each visit will include collection of biologic samples, patient-reported data and clinical assessments.
- Initial statistical analysis will begin with unsupervised clustering methods and simple logistic regression to identify biomarkers important in oral cGVHD. Based upon the results of these initial analyses, more complex multivariate statistical models will be developed to both classify and predict onset of oral cGVHD. Given the hypothesisgenerating nature of this study, additional prospective statistical analysis plans will be developed in consultation with a statistician as the study progresses to address specific scientific questions.
- Conditions
- Graft Versus Host Disease
- Keywords
- Mouth, Alloimmunity, Autoimmunity, Salivary Gland, Ulcer, Natural History
- Medical subject headings
- Graft vs Host Disease, Autoimmune Diseases, Ulcer
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 |
|---|---|---|
| Healthy-controls Longitudinal Cohort | ( Cohort HL ; approximate n=20) includes subjects who will participate in up to 4 study visits across 1 year. | |
| Healthy-controls Short-term Cohort | ( Cohort HS ; approximate n=80) will participate in a single baseline visit. | |
| New Transplant Cohort | ( Cohort NT ; approximate n=300) consists of patients who are scheduled to undergo allogeneic HSCT (under another protocol at the NIH). | |
| Prior Transplant Cohort | ( Cohort PT ; approximate n=100) consists of patients who have already undergone allogeneic HSCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 3 years from enrollment of last participant
Secondary outcomes (1)
Characterize post-transplant changes in oral cavity in presence and absence of cGVHD to develop better protocols for supportive dental care, Refine clinical definitions and classifications of oral cGVHD, Characterize longitudinal changes, includ...
- Characterize post-transplant changes in the oral cavity in the presence and absence of cGVHD to develop better protocols for supportive dental care.2. Refine clinical definitions and classifications of oral cGVHD.3. Characterize longitudinal changes in the oral microbiome4. Include healthy volunteer cohorts both as a direct control group for HSCT patients, and to characterize measures of interest that were not previously defined in the normal oral cavity.5. Test and improve criteria and tools for clinical trials
Measured: 3 years after enrollment of last participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start15 Nov 2018
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Graft Versus Host 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Janice S Lee, DDS, MD, Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602599
- Sponsor's protocol ID
- 180121
- Other IDs
- 18-D-0121
- Status last verified
- 29 Sep 2026
- First submitted
- 26 Jul 2018
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protocol is silent on IPD sharing.
Publications
Mays JW, Fassil H, Edwards DA, Pavletic SZ, Bassim CW. Oral chronic graft-versus-host disease: current pathogenesis, therapy, and research. Oral Dis. 2013 May;19(4):327-46. doi: 10.1111/odi.12028. Epub 2012 Oct 28.
PubMed 23107104Cooke KR, Luznik L, Sarantopoulos S, Hakim FT, Jagasia M, Fowler DH, van den Brink MRM, Hansen JA, Parkman R, Miklos DB, Martin PJ, Paczesny S, Vogelsang G, Pavletic S, Ritz J, Schultz KR, Blazar BR. The Biology of Chronic Graft-versus-Host Disease: A Task Force Report from the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2017 Feb;23(2):211-234. doi: 10.1016/j.bbmt.2016.09.023. Epub 2016 Oct 3.
PubMed 27713092Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.
PubMed 25529383Leinbach LI, Boroumand S, Masuch LR, Nguyen JT, Ganesan SM, Mays JW. Oral Health Characteristics 2 Years following Allogeneic Cell Transplant. J Dent Res. 2025 Sep;104(10):1061-1068. doi: 10.1177/00220345251329351. Epub 2025 May 12.
PubMed 40353516
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
- ClinicalTrials.gov ID
- NCT03602599
- Acronym / sponsor ID
- 180121
- Conditions
- Graft Versus Host Disease
- Keywords
- Mouth, Alloimmunity, Autoimmunity, Salivary Gland, Ulcer, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 27 Jul 2018 (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.
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.
Detailed description
Background:
- Chronic graft-versus-host disease (cGVHD) is a multi-organ severe alloimmune and - autoimmune disorder that occurs after allogeneic hematopoietic stem cell transplantation (HSCT). It is characterized by immune dysregulation, immunodeficiency, impaired organ function, and decreased survival.
- Manifestations of cGVHD in the oral cavity are observed in 45-85% of cGVHD patients and include 3 components: limitation of mouth opening, oral mucosal changes (lichenoid lesions, ulceration) and salivary gland changes.
- There is an urgent need for new tools to diagnose and treat oral cGVHD. To develop targeted therapies and non-invasive methods for serial screening, an improved understanding of the clinical course and underlying mechanisms of oral cGVHD are required.
Objectives:
- Advance understanding of cGVHD pathophysiology and generate hypotheses for future cGVHD studies by tracking the longitudinal development of cGVHD in the oral cavity and transplant-related changes in the oral microenvironment.
- Leverage knowledge about the impact of transplant on the oral cavity to develop better protocols for supportive dental care, to refine clinical definitions and classifications of oral cGVHD, and to test and improve criteria and tools for clinical trials.
- Include healthy volunteer cohorts both as a direct control group for HSCT patients, and to characterize measures of interest that were not previously defined in the normal oral cavity.
Eligibility:
- Patients who are scheduled to undergo allogeneic HSCT at the National Institutes of Health (NIH) or who have already undergone allogeneic HSCT at the NIH or elsewhere.
- Healthy individuals who have not undergone transplant and are willing to undergo oral exam and sample collection will be included in a control group.
- All study subjects, including patients and healthy individuals, must be able to provide written informed consent and be willing to return to the NIH Dental Clinic for scheduled evaluations.
Design:
- This is a single site, observational study with four cohorts. There are 2 transplant cohorts: the New Transplant Cohort ("Cohort NT"; approximate n=300) consists of patients who are scheduled to undergo allogeneic HSCT (under another protocol at the NIH) and the Prior Transplant Cohort ("Cohort PT"; approximate n=100) consists of patients who have already undergone allogeneic HSCT. These Cohorts will have up to 7 regularly scheduled visits across 3 years, along with a variable number of acute-episode visits. Subjects enrolled as NT or PT, who require a subsequent transplant are eligible to be either enrolled or re-enrolled into the PT cohort to be followed for the 7 visits in 3 years. Additionally, subjects will have the opportunity to participate in optional annual follow-up visits in years 4-10 post transplant.
- The other 2 Cohorts include healthy volunteers: the Healthy-controls Longitudinal (HL) Cohort ("Cohort HL"; approximate n=20) includes subjects who will participate in up to 4 study visits across 1 year, and the Healthy-controls Short-term (HS) Cohort ("Cohort HS"; approximate n=80) will participate in a single baseline visit.
- Each visit will include collection of biologic samples, patient-reported data and clinical assessments.
- Initial statistical analysis will begin with unsupervised clustering methods and simple logistic regression to identify biomarkers important in oral cGVHD. Based upon the results of these initial analyses, more complex multivariate statistical models will be developed to both classify and predict onset of oral cGVHD. Given the hypothesisgenerating nature of this study, additional prospective statistical analysis plans will be developed in consultation with a statistician as the study progresses to address specific scientific questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy-controls Longitudinal Cohort | – | –( Cohort HL ; approximate n=20) includes subjects who will participate in up to 4 study visits across 1 year. |
| Healthy-controls Short-term Cohort | – | –( Cohort HS ; approximate n=80) will participate in a single baseline visit. |
| New Transplant Cohort | – | –( Cohort NT ; approximate n=300) consists of patients who are scheduled to undergo allogeneic HSCT (under another protocol at the NIH). |
| Prior Transplant Cohort | – | –( Cohort PT ; approximate n=100) consists of patients who have already undergone allogeneic HSCT. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects in Cohort NT and Cohort PT will be scheduled to undergo allogeneic hematopoietic stem cell transplant at the NIH (Cohort NT) or have already undergone allogeneic HSCT at the NIH or another institution (Cohort PT) and are within 3 years of most recent bone marrow transplant. Subjects in Cohort HL and Cohort HS will be healthy volunteers and may potentially be age- and/or sex-matched with a transplant patient participant. All subjects will be at least 18 years of age.
Key inclusion criteria (12 listed)
- Subjects in Cohort NT and Cohort PT must satisfy all of the following criteria in order to participate in the study:
- Subjects in Cohort HL and Cohort HS must satisfy all of the following criteria in order to participate in the study:
- Subjects in Cohort HL must additionally be willing and able to return to the NIH Dental Clinic for scheduled visits across 1 year and participate in evaluations including saliva collection, oral swab collection, and completion of PRO forms
Key exclusion criteria (7 listed)
- Subjects in any Cohort will be excluded if they are pregnant, as pregnancy can have a confounding effect on the oral microbiome
- Subjects in Cohort NT may not participate in the study if, in the opinion of the NIH transplant team, participation in the protocol would not be safe or in the subject s best interest
- Subjects in Cohort PT. There are no additional exclusion criteria for subjects in this cohort.
- Subjects in Cohorts HL and Cohort HS may not participate in the study if they meet either of the following criteria:
- Subjects in Cohort HL additionally may not participate if they are planning to become pregnant within the next year or refuse to have oral biopsies.
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
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.
Time frame: 3 years from enrollment of last participant
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.
1 secondary outcome
Characterize post-transplant changes in oral cavity in presence and absence of cGVHD to develop better protocols for supportive dental care, Refine clinical definitions and classifications of oral cGVHD, Characterize longitudinal changes, includ...
Time frame: 3 years after enrollment of last participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 23107104Mays JW, Fassil H, Edwards DA, Pavletic SZ, Bassim CW. Oral chronic graft-versus-host disease: current pathogenesis, therapy, and research. Oral Dis. 2013 May;19(4):327-46. doi: 10.1111/odi.12028. Epub 2012 Oct 28.
- Background: PubMed 27713092Cooke KR, Luznik L, Sarantopoulos S, Hakim FT, Jagasia M, Fowler DH, van den Brink MRM, Hansen JA, Parkman R, Miklos DB, Martin PJ, Paczesny S, Vogelsang G, Pavletic S, Ritz J, Schultz KR, Blazar BR. The Biology of Chronic Graft-versus-Host Disease: A Task Force Report from the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2017 Feb;23(2):211-234. doi: 10.1016/j.bbmt.2016.09.023. Epub 2016 Oct 3.
- Background: PubMed 25529383Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.
- Derived from this study: PubMed 40353516Leinbach LI, Boroumand S, Masuch LR, Nguyen JT, Ganesan SM, Mays JW. Oral Health Characteristics 2 Years following Allogeneic Cell Transplant. J Dent Res. 2025 Sep;104(10):1061-1068. doi: 10.1177/00220345251329351. Epub 2025 May 12.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Protocol is silent on IPD sharing.
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Graft vs Host Disease
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.
Janice S Lee, DDS, MD principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Versus Host Disease, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
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 12 inclusion and 7 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 years from enrollment of last participant). 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 NCT03602599, which also lists 4 linked publications.
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 1 Oct 2026.