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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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 graft-versus-host disease (GVHD)
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
Otros nombres:
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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.
|
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subsets and activation status of B, T, and NK lymphocytes
Periodo de tiempo: Up to 2 months
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Side by side box plots with overlaid plotted points will be used to assess potential differences in continuous markers between groups.
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Up to 2 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Logistical challenges with obtaining and processing samples in each of the subgroups of interest
Periodo de tiempo: Up to 2 months
|
Up to 2 months
|
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Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
Periodo de tiempo: Up to 2 months
|
Up to 2 months
|
|
Differences in cytokines in patients with cGVHD vs. those without
Periodo de tiempo: Up to 2 months
|
Up to 2 months
|
|
Differences in in lymphocyte activation between those with vs. without cGVHD
Periodo de tiempo: Up to 2 months
|
Up to 2 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Samantha Jaglowski, MD, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OSU-12208
- NCI-2013-01641 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
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