NCT00751309

Lung Allograft Rejection Gene Expression Observational (LARGO) Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2,044 (actual)
• Sponsor: XDx · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Graft Rejection
• Lung Disease

Interventions

Type	Name	Description
OTHER	Non-interventional	Post-transplantation observational study

Timeline

• Start date: 2004-04-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-09-11
• Last updated: 2008-12-18

Locations

20 sites across 5 countries: United States, Austria, Canada, Germany, United Kingdom