- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01988701
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
Andra namn:
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Subsets and activation status of B, T, and NK lymphocytes
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Logistical challenges with obtaining and processing samples in each of the subgroups of interest
Tidsram: Up to 2 months
|
Up to 2 months
|
Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
Tidsram: Up to 2 months
|
Up to 2 months
|
Differences in cytokines in patients with cGVHD vs. those without
Tidsram: Up to 2 months
|
Up to 2 months
|
Differences in in lymphocyte activation between those with vs. without cGVHD
Tidsram: Up to 2 months
|
Up to 2 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Samantha Jaglowski, MD, Ohio State University Comprehensive Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OSU-12208
- NCI-2013-01641 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Hematopoetisk/lymfoid cancer
-
International Extranodal Lymphoma Study Group (IELSG)Aktiv, inte rekryterandeMucosa Associated Lymphoid Tissue (MALT) lymfomSpanien, Italien, Österrike
-
Grupo Español de Linfomas y Transplante Autólogo...Avslutad
Kliniska prövningar på Ancillary-Correlative
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RekryteringNy 3D hematologisk malignitetsorganoid för att studera sjukdomsbiologi och kemokänslighet (Organoid)Hematologisk malignitetFörenta staterna