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Lung Allograft Rejection Gene Expression Observational (LARGO) Study (LARGO)

17. december 2008 opdateret af: XDx
The objective of the LARGO Study protocol is to collect peripheral blood samples, select associated lung biopsy pathology slides, and clinical data from lung transplant recipients to perform molecular analyses in association with the study endpoints. The primary objective is to use gene expression profiling of peripheral blood mononuclear cells to differentiate between the absence and presence of acute cellular rejection. The secondary objectives are to use other genomic and proteomic technologies to analyze RNA and protein in blood samples in relation to related clinical conditions. The overall goal is to apply novel molecular insights in the development of non-invasive molecular diagnostic tests for lung transplantation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

LARGO is a prospective, multi-center, international observational study with participating centers in the United States, Canada and Europe. The target enrollment for study completion is 2,100 subjects.

At each study visit, blood specimens are collected from subjects, processed and stored in the sample archive, with corresponding patient information entered into the clinical database. The analysis plan for each study objective includes a defined sample selection protocol that stipulates the inclusion and exclusion criteria for both patients and samples, and also the required number of blood specimens for the molecular analyses to achieve statistical significance.

The diagnosis and treatment of acute cellular rejection remains a clinical management priority that is currently based on transbronchial biopsy. Gene expression profiling is a technology based on molecular biology that measures changes in the RNA levels of different genes expressed by circulating mononuclear cells in the peripheral blood. A key goal of the project is to use gene expression profiling to differentiate between the absence and presence of lung allograft acute cellular rejection, with the aim of using this novel information to develop a non-invasive diagnostic testing alternative.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2044

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • Det Forenede Kongerige
    • Newcastle upon Tyne
      • High Heaton, Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
        • Freeman Hospital
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA Division of Pulmonary and Critical Care
      • San Francisco, California, Forenede Stater, 94117
        • University of California, San Francisco
      • Stanford, California, Forenede Stater, 94305
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic Transplant Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Health Systems
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • St. Louis, Missouri, Forenede Stater, 63110
        • St. Louis Children's Hospital
    • New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University College of Physicians and Surgeons
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • The Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15261
        • University of Pittsburgh
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University Hospital and Clinics
  • Tyskland
      • Hannover, Tyskland, 30625
        • Medizinische Hochschule Hannover
  • Østrig
      • Vienna, Østrig, 1090
        • Medizinische Universität Wien

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

Lung and heart-lung transplant recipients who will undergo transbronchial biopsy.

Beskrivelse

Inclusion Criteria:

  • Lung and heart-lung transplant recipients who consent to participate and have transbronchial biopsy at the enrolling center during the study period

Exclusion Criteria:

  • None

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
Lung and heart-lung transplanted subjects.
Andet: Non-interventional
Post-transplantation observational study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Rejection episodes of at least moderate histologic grade which resulted in treatment of the patient with additional corticosteroids, anti-T cell antibodies, or total lymphoid irradiation.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
Obliterative Bronchiolitis diagnosed pathologically by biopsy or by a progressive decline in pulmonary function tests consistent with a diagnosis of Bronchiolitis Obliterans Syndrome (BOS).
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
Allograft function as determined via pulmonary function tests.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
The absence of histologic rejection and normal or unchanged allograft function.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
Infections other than CMV, e.g. bacterial, other viral, and fungal infections.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit

Sekundære resultatmål

Resultatmål
Tidsramme
Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
Allograft dysfunction during the study period.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
Lymphoproliferative disorder (aka post-transplant lymphoma).
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
Graft Failure or Retransplantation.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit
All cause mortality.
Tidsramme: Scheduled clinic visit
Scheduled clinic visit

Samarbejdspartnere og efterforskere

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

Sponsor

XDx

Efterforskere

  • Studieleder: Kenneth C. Fang, MD, XDx, Inc.

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. april 2004

Primær færdiggørelse (Forventet)

1. januar 2009

Studieafslutning (Forventet)

1. januar 2009

Datoer for studieregistrering

Først indsendt

10. september 2008

Først indsendt, der opfyldte QC-kriterier

10. september 2008

Først opslået (Skøn)

11. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. december 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. december 2008

Sidst verificeret

1. december 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LARGO

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 .

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