Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation
Purpose
This study evaluates the factors that contribute to chronic graft-versus-host disease, which is a complication that can occur after allogeneic hematopoietic cell transplantation.
Conditions
- Graft Versus Host Disease
- Hematopoietic and Lymphatic System Neoplasm
- Malignant Solid Neoplasm
Eligibility
- Eligible Ages
- Over 7 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- * BOTH COHORTS: - Documented written informed consent of the participant and/or parent/guardian. - Assent from pediatric participants will be documented per institutional policies and practice. - Patients who have received allogeneic hematopoietic cell transplant (HCT) regardless of donor type, condition regimen, or GVHD prophylaxis. - Age: ≥ 18 years or ≥ 7 years if 30 kg and above - Willingness to: - Provide blood sample(s), stool, saliva, and buccal mucosa, - If applicable: Permit medical record/ clinical laboratory result review - COHORT 1: - Patients who have received allogeneic hematopoietic cell transplant (HCT) regardless of donor type, condition regimen, or GVHD prophylaxis. - COHORT 2: - Patients diagnosed with cGVHD at any time-point after allogeneic HCT regardless of donor type, condition regimen, or GVHD prophylaxis.
Exclusion Criteria
- * Women of childbearing potential: Pregnant/nursing - Individuals with impaired decision-making capacity - An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager - A direct study team member
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational Cohort 1 | Patients undergo blood, saliva/buccal, and stool sample collection for up to 2 years on study. Patients also have their medical records reviewed on study. |
|
| Observational Cohort 2 | Patients undergo a one-time blood, saliva/buccal, and stool sample collection and have their medical records reviewed on study. |
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Recruiting Locations
City of Hope Medical Center
Duarte, California 91010
Duarte, California 91010
More Details
- Status
- Recruiting
- Sponsor
- City of Hope Medical Center
Study Contact
Detailed Description
PRIMARY OBJECTIVE: I. Characterize immune cells and their subsets in peripheral blood of patients who develop and do not develop chronic graft-versus-host disease (cGVHD). OUTLINE: This is an observational study. Patients are assigned to 1 of 2 cohorts. COHORT 1: Patients undergo blood, saliva/buccal, and stool sample collection for up to 2 years on study. Patients also have their medical records reviewed on study. COHORT 2: Patients undergo a one-time blood, saliva/buccal, and stool sample collection and have their medical records reviewed on study.