Understanding mouth problems after stem cell transplants
Natural History of Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
This study is looking at mouth problems in patients who have had stem cell transplants to see how these issues develop and how they can be treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03602599 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track changes in the oral cavity of patients who have undergone or are scheduled for allogeneic hematopoietic stem cell transplantation (HSCT) to identify chronic graft-versus-host disease (cGVHD). Participants will undergo a series of evaluations, including medical history assessments, dental exams, and saliva collection, to better understand the development and treatment of oral cGVHD. The study also includes healthy controls to provide comparative data on oral health. By advancing knowledge of cGVHD's impact on the mouth, the research seeks to improve diagnostic tools and treatment protocols.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing or have recently undergone allogeneic HSCT.
Not a fit: Patients who are not undergoing HSCT or are outside the three-year post-transplant window may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and management of oral complications in patients post-transplant.
How similar studies have performed: While there is ongoing research into cGVHD, this study's specific focus on oral manifestations and healthy controls is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * 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 * 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 EXCLUSION CRITERIA: * 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jacqueline W Mays, D.D.S. — National Institute of Dental and Craniofacial Research (NIDCR)
- Study coordinator: Licia R Masuch
- Email: licia.masuch@nih.gov
- Phone: (301) 335-0113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.