Lung Allograft Rejection Gene Expression Observational (LARGO) Study

Lung Disease Clinical Trial

— LARGO  

Official title:

Lung Allograft Rejection Gene Expression Observational (LARGO) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00751309
• Other study ID #: LARGO
• Status: Terminated
• Phase: N/A
• First received: September 10, 2008
• Last updated: December 17, 2008
• Start date: April 2004
• Est. completion date: January 2009

Study information

• Verified date: December 2008
• Source: XDx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeGermany: Ethics CommissionCanada: Ethics Review CommitteeAustria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2044
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Graft Rejection
• Lung Disease
• Lung Diseases

Intervention

Other:
• Non-interventional
Post-transplantation observational study

Locations

Country	Name	City	State
Austria	Medizinische Universität Wien	Vienna
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Germany	Medizinische Hochschule Hannover	Hannover
United Kingdom	Freeman Hospital	High Heaton	Newcastle upon Tyne
United States	University of Michigan Health Systems	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Mayo Clinic Transplant Center	Jacksonville	Florida
United States	UCLA Division of Pulmonary and Critical Care	Los Angeles	California
United States	University Hospital and Clinics	Madison	Wisconsin
United States	Columbia University College of Physicians and Surgeons	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	St. Louis Children's Hospital	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
XDx

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Allograft function as determined via pulmonary function tests.		Scheduled clinic visit	No
Primary	The absence of histologic rejection and normal or unchanged allograft function.		Scheduled clinic visit	No
Primary	Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection.		Scheduled clinic visit	No
Primary	Infections other than CMV, e.g. bacterial, other viral, and fungal infections.		Scheduled clinic visit	No
Secondary	Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen.		Scheduled clinic visit	No
Secondary	Allograft dysfunction during the study period.		Scheduled clinic visit	No
Secondary	Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection.		Scheduled clinic visit	No
Secondary	Lymphoproliferative disorder (aka post-transplant lymphoma).		Scheduled clinic visit	No
Secondary	Graft Failure or Retransplantation.		Scheduled clinic visit	No
Secondary	All cause mortality.		Scheduled clinic visit	No

External Links

•   Sponsor's website