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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-04424 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24871 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| R01HL170099 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| T cell measurements | Defined as percentage of naïve and memory T cells using high dimensional flow cytometry. | Up to 2 years - study completion |
| B cell measurements | Defined as percentage of naïve B, memory B, and plasma cells using high dimensional flow cytometry. | Up to 2 years - study completion |
| Macrophage measurements | Defined as percentage of M1, M2, and M0 using high dimensional flow cytometry. | Up to 2 years - study completion |
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Inclusion Criteria:
* BOTH COHORTS:
Documented written informed consent of the participant and/or parent/guardian.
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
Patients who have received allogeneic hematopoietic cell transplant (HCT) regardless of donor type, condition regimen, or GVHD prophylaxis.
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
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Patients who have received allogeneic hematopoietic cell transplant.
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| Name | Affiliation | Role |
|---|---|---|
| Ryotaro Nakamura | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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