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Lymphocyte Profiles and Activation Status in Patients With Graft-Versus-Host Disease

26. februar 2015 opdateret af: Samantha Jaglowski, Ohio State University Comprehensive Cancer Center

Lymphocyte Profiles and Activation Status in the Development of Chronic Graft-versus-Host Disease

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.

Studieoversigt

Status

Trukket tilbage

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who have received an autologous stem cell transplant and stem cell transplant at The Ohio State University.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.
Andre navne:
  • laboratoriebiomarkøranalyse
  • Correlatives studies
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.
Andre navne:
  • laboratoriebiomarkøranalyse
  • Correlatives studies

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subsets and activation status of B, T, and NK lymphocytes
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
Logistical challenges with obtaining and processing samples in each of the subgroups of interest
Tidsramme: Up to 2 months
Up to 2 months
Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
Tidsramme: Up to 2 months
Up to 2 months
Differences in cytokines in patients with cGVHD vs. those without
Tidsramme: Up to 2 months
Up to 2 months
Differences in in lymphocyte activation between those with vs. without cGVHD
Tidsramme: Up to 2 months
Up to 2 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Samantha Jaglowski, MD, Ohio State University Comprehensive Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2015

Primær færdiggørelse (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

14. november 2013

Først indsendt, der opfyldte QC-kriterier

14. november 2013

Først opslået (Skøn)

20. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OSU-12208
  • NCI-2013-01641 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hæmatopoietisk/lymfoid kræft

3
Abonner