Protocol Details
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 currently recruiting participants.
Summary
Number | 18-D-0121 |
Sponsoring Institute | National Institute of Dental And Craniofacial Research (NIDCR) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years |
Referral Letter Required | No |
Population Exclusion(s) | Children;
Adults who are or may become unable to consent;
Pregnant Women |
Keywords | Mouth;
Alloimmunity;
Autoimmunity;
Salivary Gland;
Ulcer;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Graft Versus Host Disease |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Dental and Craniofacial Research |
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.
Eligibility
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.
Citations:
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. Cooke 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. Jagasia 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.
Contacts:
Clinical Trials Number:
NCT03602599