Natural History of Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Healthy-controls Short-term Cohort
( Cohort HS ; approximate n=80) will participate in a single baseline visit.
Prior Transplant Cohort
( Cohort PT ; approximate n=100) consists of patients who have already undergone allogeneic HSCT.
Healthy-controls Longitudinal Cohort
( Cohort HL ; approximate n=20) includes subjects who will participate in up to 4 study visits across 1 year.
New Transplant Cohort
( Cohort NT ; approximate n=300) consists of patients who are scheduled to undergo allogeneic HSCT (under another protocol at the NIH).
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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...(3 years after enrollment of last participant)
- 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...(3 years after enrollment of last participant)