Overview
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.
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.
Eligibility
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.
- Documented written informed consent of the participant and/or parent/guardian.
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
