RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2018-11-15
Study Completion:2026-03-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03602599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects in Cohort NT and Cohort PT must satisfy all of the following criteria in order to participate in the study:
  2. * 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
  3. * Willing to participate in protocol evaluations including saliva collection, oral swab collection, and completion of patient-reported outcome (PRO) forms
  4. * Willing to return to the NIH Dental Clinic for scheduled evaluations
  5. * Be at least 18 years of age at screening
  6. * Be able to understand and provide written informed consent
  7. * Subjects in Cohort HL and Cohort HS must satisfy all of the following criteria in order to participate in the study:
  8. * Willing to undergo oral exam and participate in Visit 1 protocol evaluations including saliva collection, oral swab collection and oral biopsies.
  9. * Be at least 18 years of age at screening
  10. * Be able to understand and provide written informed consent
  11. * Potentially be age- and/or sex-matched with a transplant patient
  12. * 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
  1. * Subjects in any Cohort will be excluded if they are pregnant, as pregnancy can have a confounding effect on the oral microbiome
  2. * 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
  3. * Subjects in Cohort PT. There are no additional exclusion criteria for subjects in this cohort.
  4. * Subjects in Cohorts HL and Cohort HS may not participate in the study if they meet either of the following criteria:
  5. * 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
  6. * Are taking medications or are on other ongoing therapies that have a known or suspected major impact on the oral microbiome
  7. * 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.

Contacts and Locations

Study Contact

Licia R Masuch
CONTACT
(301) 335-0113
licia.masuch@nih.gov
Jacqueline W Mays, D.D.S.
CONTACT
(301) 496-8800
jacqueline.mays@nih.gov

Principal Investigator

Jacqueline W Mays, D.D.S.
PRINCIPAL_INVESTIGATOR
National Institute of Dental and Craniofacial Research (NIDCR)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

  • Jacqueline W Mays, D.D.S., PRINCIPAL_INVESTIGATOR, National Institute of Dental and Craniofacial Research (NIDCR)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-15
Study Completion Date2026-03-03

Study Record Updates

Study Start Date2018-11-15
Study Completion Date2026-03-03

Terms related to this study

Keywords Provided by Researchers

  • Mouth
  • Alloimmunity
  • Autoimmunity
  • Salivary Gland
  • Ulcer
  • Natural History

Additional Relevant MeSH Terms

  • Graft Versus Host Disease