Early Indicators of Chronic Rejection in Lung Transplant (BOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00449332
Recruitment Status : Terminated (PI left University)
First Posted : March 20, 2007
Last Update Posted : September 20, 2016
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The purpose of this research is to discover the different patterns of cytokine production in patients who may develop Bronchiolitis Obliterans Syndrome-0p (BOS-0p) which means ongoing rejection. This is an early indicator of chronic rejection in lung transplant recipients. These cytokines can be detected in the bronchoalveolar (lung) and tissue samples of lung transplant recipients.

Condition or disease
Chronic Rejection in Lung Transplant Cytokine Production in Bos Post Lung Transplant

Detailed Description:
Lung transplant recipients are routinely followed in clinic every three months after the first year post-transplant. Spirometry with measurement of FEV1, FVC and FEF25-75 are obtained at each visit. In addition, lung transplant recipients undergo surveillance bronchoscopy at one, three, six, nine and twelve months. All bronchoscopy specimens that are obtained for this study will be obtained during bronchoscopies that were scheduled per the physician caring for the patient. An extra 90 cc of sterile solution will be instilled into bronchus and two extra transbronchial biopsies will be performed in addition to the routine bronchoscopic procedure. Routinely, 4-8 transbronchial biopsy samples are obtained from the transplanted lung. Two specimens will be randomly selected for study and the rest will undergo routine histopathologic study. The study biopsies will be set aside and processed. The study visits for this research will occur at the same time as standard of care post transplant visits. We will collect subject's history,demographic of subject's transplant data,donor procurement information, physical exam information, pregnancy tests,blood test and spirometry results from the visits mentioned above.

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Inflammatory and Fibroproliferative Cytokines in the Pathogenesis of Bronchiolitis Obliterans Syndrome-OP in Lung Transplant Recipients.
Study Start Date : March 2006
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. cytokines, chemokines and T cell subsets associated with BOS [ Time Frame: 12/2013 ]

Biospecimen Retention:   Samples With DNA
lung tissues, bal, blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post lung transplant patients

Inclusion Criteria:

  • Lung transplant recipients between the ages of 18 and 65 years old
  • All patients must be able to give written informed consent

Exclusion Criteria:

  • Lung transplant recipients who are unable to undergo bronchoscopy
  • Lung transplant recipients who are unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00449332

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Sangeeta M Bhorade, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT00449332     History of Changes
Other Study ID Numbers: 14516A
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by University of Chicago:
Chronic rejection, lung transplant, cytokines, bos

Additional relevant MeSH terms:
Bronchiolitis Obliterans
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases