Graft RejectionLARGONCT00751309
Lung Allograft Rejection Gene Expression Observational (LARGO) Study
An observational study of Graft Rejection and Lung Disease, run by XDx at 20 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Graft Rejection, Lung Disease
- What is being tested?
- Non-interventional
- How many people
- 2,044 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Apr 2004to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Lung and heart-lung transplant recipients who will undergo transbronchial biopsy.
Who may be able to join
- Lung and heart-lung transplant recipients who consent to participate and have transbronchial biopsy at the enrolling center during the study period
Who cannot join
- None
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United States15 sites
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
The Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Mayo Clinic Transplant Center
Jacksonville, Florida, 32224
UCLA Division of Pulmonary and Critical Care
Los Angeles, California, 90095
University Hospital and Clinics
Madison, Wisconsin, 53792
Columbia University College of Physicians and Surgeons
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
University of California, San Francisco
San Francisco, California, 94117
University of Washington Medical Center
Seattle, Washington, 98195
St. Louis Children's Hospital
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University School of Medicine
Stanford, California, 94305
Canada2 sites
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
United Kingdom1 site
Freeman Hospital
High Heaton, Newcastle upon Tyne, NE7 7DN
About this 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.
Read the 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
- Being tested
- Non-interventional
- Keywords
- allograft, rejection, biopsy, gene, expression, pulmonary, lung, transplant
- Medical subject headings
- Lung Diseases, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Post-transplantation observational study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Lung and heart-lung transplanted subjects. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Scheduled clinic visit
Allograft function as determined via pulmonary function tests.
Measured: Scheduled clinic visit
The absence of histologic rejection and normal or unchanged allograft function.
Measured: Scheduled clinic visit
Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection.
Measured: Scheduled clinic visit
Infections other than CMV, e.g. bacterial, other viral, and fungal infections.
Measured: Scheduled clinic visit
Secondary outcomes (6)
Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen.
Measured: Scheduled clinic visit
Allograft dysfunction during the study period.
Measured: Scheduled clinic visit
Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection.
Measured: Scheduled clinic visit
Lymphoproliferative disorder (aka post-transplant lymphoma).
Measured: Scheduled clinic visit
Graft Failure or Retransplantation.
Measured: Scheduled clinic visit
All cause mortality.
Measured: Scheduled clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startApr 2004
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Why it stopped: Restructuring and refocus of company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- XDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kenneth C. Fang, MD, Study director, XDx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751309
- Sponsor's protocol ID
- LARGO
- Acronym
- LARGO
- Status last verified
- Dec 2008
- First submitted
- 10 Sep 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Allograft Rejection Gene Expression Observational (LARGO) Study
- ClinicalTrials.gov ID
- NCT00751309
- Acronym / sponsor ID
- LARGO / LARGO
- Conditions
- Graft Rejection, Lung Disease
- Keywords
- allograft, rejection, biopsy, gene, expression, pulmonary, lung, transplant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Restructuring and refocus of company.
- Enrolment
- 2,044 participants (actual)
- Lead sponsor
- XDxIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 11 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Non-interventionalLung and heart-lung transplanted subjects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lung and heart-lung transplant recipients who will undergo transbronchial biopsy.
Key inclusion criteria (1 listed)
- Lung and heart-lung transplant recipients who consent to participate and have transbronchial biopsy at the enrolling center during the study period
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalPost-transplantation observational study | Other | 1 |
Primary outcome
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
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
Allograft function as determined via pulmonary function tests.
Time frame: Scheduled clinic visit
The absence of histologic rejection and normal or unchanged allograft function.
Time frame: Scheduled clinic visit
Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection.
Time frame: Scheduled clinic visit
Infections other than CMV, e.g. bacterial, other viral, and fungal infections.
Time frame: Scheduled clinic visit
6 secondary outcomes
Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen.
Time frame: Scheduled clinic visit
Allograft dysfunction during the study period.
Time frame: Scheduled clinic visit
Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection.
Time frame: Scheduled clinic visit
Lymphoproliferative disorder (aka post-transplant lymphoma).
Time frame: Scheduled clinic visit
Graft Failure or Retransplantation.
Time frame: Scheduled clinic visit
All cause mortality.
Time frame: Scheduled clinic visit
Results and safety
The study was stopped early (reason given: Restructuring and refocus of company.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2008.
- Information on molecular expression testingLink provided by the sponsor.
- Sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth C. Fang, MD study director
XDx, Inc.
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Rejection and Lung Disease, run by XDx at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada, Austria, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Restructuring and refocus of company.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2008.