Lung Allograft Rejection Gene Expression Observational (LARGO) Study

This study has been terminated.
(Restructuring and refocus of company.)
Sponsor:
Information provided by:
XDx
ClinicalTrials.gov Identifier:
NCT00751309
First received: September 10, 2008
Last updated: December 17, 2008
Last verified: December 2008

September 10, 2008
December 17, 2008
April 2004
January 2009   (final data collection date for primary outcome measure)
  • 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. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • Obliterative Bronchiolitis diagnosed pathologically by biopsy or by a progressive decline in pulmonary function tests consistent with a diagnosis of Bronchiolitis Obliterans Syndrome (BOS). [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • Allograft function as determined via pulmonary function tests. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • The absence of histologic rejection and normal or unchanged allograft function. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • Infections other than CMV, e.g. bacterial, other viral, and fungal infections. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00751309 on ClinicalTrials.gov Archive Site
  • Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • Allograft dysfunction during the study period. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • Lymphoproliferative disorder (aka post-transplant lymphoma). [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • Graft Failure or Retransplantation. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: Scheduled clinic visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lung Allograft Rejection Gene Expression Observational (LARGO) Study
Lung Allograft Rejection Gene Expression Observational (LARGO) Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

venous blood plasma

Non-Probability Sample

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

  • Graft Rejection
  • Lung Disease
Other: Non-interventional
Post-transplantation observational study
1
Lung and heart-lung transplanted subjects.
Intervention: Other: Non-interventional
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2044
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Germany,   United Kingdom
 
NCT00751309
LARGO
No
Kenneth C. Fang, MD, XDx, Inc.
XDx
Not Provided
Study Director: Kenneth C. Fang, MD XDx, Inc.
XDx
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP