Clinical trial · Observational
Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation
NCT07235501CI-TRIAL-00124174not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Observational Cohort 1
- description
- 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.
- interventionNames
- Other: Non-Interventional Study
- label
- Observational Cohort 2
- description
- Patients undergo a one-time blood, saliva/buccal, and stool sample collection and have their medical records reviewed on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (3)
- measure
- T cell measurements
- timeFrame
- Up to 2 years - study completion
- description
- Defined as percentage of naïve and memory T cells using high dimensional flow cytometry.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
Show eligibility criteria text
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 memberReferences
Publications (0)
Data not yet available
No reference posted for this study.