Trials / Withdrawn
WithdrawnNCT01988701
Lymphocyte Profiles and Activation Status in Patients With Graft-Versus-Host Disease
Lymphocyte Profiles and Activation Status in the Development of Chronic Graft-versus-Host Disease
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This research trial studies lymphocyte profiles and activation status in patients with graft-versus-host disease. Studying samples of blood in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to graft-versus-host disease.
Detailed description
PRIMARY OBJECTIVES: I. To explore and assess changes in subsets and activation status of B-, T,-, and natural killer (NK) lymphocytes in peripheral blood following allogeneic stem cell transplant and how they may be associated with clinical events with an ultimate future goal of conducting a larger successor study to identify potential therapeutic targets based on its findings. SECONDARY OBJECTIVES: I. To assess the feasibility of obtaining and comparing patients with chronic graft-versus-host disease (cGVHD) with time-matched stem cell transplant (SCT) patients without cGVHD and identify logistical challenges with obtaining and processing samples in each of the subgroups of interest for these analyses. II. To assess and explore differences in lymphocyte subsets (B-, T-, and NK) between those with vs. without cGVHD. III. To assess and explore differences in cytokines in patients with cGVHD vs. those without. IV. To describe lymphocyte subsets and activation and explore how these may be related to specific clinical manifestations of cGVHD. OUTLINE: Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunosorbent spot (ELISPOT), immunoblot, and microarray assays.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Ancillary-Correlative | Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays. |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2016-12-01
- First posted
- 2013-11-20
- Last updated
- 2015-03-02
Source: ClinicalTrials.gov record NCT01988701. Inclusion in this directory is not an endorsement.