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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
Autres noms:
|
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Subsets and activation status of B, T, and NK lymphocytes
Délai: Up to 2 months
|
Side by side box plots with overlaid plotted points will be used to assess potential differences in continuous markers between groups.
|
Up to 2 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Logistical challenges with obtaining and processing samples in each of the subgroups of interest
Délai: Up to 2 months
|
Up to 2 months
|
|
Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
Délai: Up to 2 months
|
Up to 2 months
|
|
Differences in cytokines in patients with cGVHD vs. those without
Délai: Up to 2 months
|
Up to 2 months
|
|
Differences in in lymphocyte activation between those with vs. without cGVHD
Délai: Up to 2 months
|
Up to 2 months
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Samantha Jaglowski, MD, Ohio State University Comprehensive Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OSU-12208
- NCI-2013-01641 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
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