Lung Allograft Rejection Gene Expression Observational (LARGO) Study

NCT00751309 | Terminated

• 1 other identifier: LARGO
• Study Type: observational
• Target: 2,044
• Locations: 5 countries
• Sites: 20

Brief Summary

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.

Conditions

Graft Rejection; Lung Disease

Keywords

allograft; rejection; biopsy; gene; expression; pulmonary; lung; transplant

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  Scheduled clinic visit

• Allograft function as determined via pulmonary function tests.

  Scheduled clinic visit

• The absence of histologic rejection and normal or unchanged allograft function.

  Scheduled clinic visit

• Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection.

  Scheduled clinic visit

• Infections other than CMV, e.g. bacterial, other viral, and fungal infections.

  Scheduled clinic visit

Secondary Outcomes (6)

• Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen.

  Scheduled clinic visit

• Allograft dysfunction during the study period.

  Scheduled clinic visit

• Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection.

  Scheduled clinic visit

• Lymphoproliferative disorder (aka post-transplant lymphoma).

  Scheduled clinic visit

• Graft Failure or Retransplantation.

  Scheduled clinic visit

Study Arms (1)

1

Lung and heart-lung transplanted subjects.

Other: Non-interventional

Interventions

Non-interventional OTHER

Post-transplantation observational study

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• XDx: lead

Study Sites (20)

UCLA Division of Pulmonary and Critical Care

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94117, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Mayo Clinic Transplant Center

Jacksonville, Florida, 32224, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Freeman Hospital

High Heaton, Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Links

• Information on molecular expression testing
• Sponsor's website

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood plasma

MeSH Terms

Conditions

Lung Diseases; Rejection, Psychology

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Social Behavior; Behavior

Study Officials

• Kenneth C. Fang, MD

  XDx, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: April 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

DE (1); US (15); AU (1); CA (2); GB (1)