Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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.
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T cell measurements | Up to 2 years - study completion | Defined as percentage of naïve and memory T cells using high dimensional flow cytometry. |
| B cell measurements | Up to 2 years - study completion | Defined as percentage of naïve B, memory B, and plasma cells using high dimensional flow cytometry. |
| Macrophage measurements | Up to 2 years - study completion | Defined as percentage of M1, M2, and M0 using high dimensional flow cytometry. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRyotaro Nakamura
City of Hope Medical Center
Outcome results
None listed