Lymphocyte Profiles and Activation Status in Patients With Graft-Versus-Host Disease
NCT ID: NCT01988701
Last Updated: 2015-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2015-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Allogeneic SCT Groups
Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic GVHD.
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.
Autologous SCT group
Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Autologous SCT group: Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Samantha Jaglowski
Principal Investigator
Principal Investigators
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Samantha Jaglowski, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Related Links
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The Jamesline
Other Identifiers
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NCI-2013-01641
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-12208
Identifier Type: -
Identifier Source: org_study_id
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