Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls

Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Jul 26, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a condition called chronic graft-versus-host disease (cGVHD), which can occur after patients receive stem cell transplants from donors. Specifically, the focus is on how cGVHD affects the mouth, as it can lead to issues like pain, sensitivity, and dryness. The researchers aim to learn more about the changes that happen in the mouth after transplantation and find better ways to identify and treat these problems.

To participate in the study, you need to be at least 18 years old and either be scheduled for a stem cell transplant or have had one within the last three years. Healthy adults can also join the study for comparison. Participants will go through several visits, including dental exams, taking saliva samples, and possibly having small biopsies (tiny samples of tissue) taken from the inside of the mouth. Most participants will have at least seven visits over three years, where they will meet with dental specialists and repeat some tests to monitor any changes. It's important to know that if you are pregnant or have certain health issues, you may not be eligible for the study.

Gender

ALL

Eligibility 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.