Early Indicators of Chronic Rejection in Lung Transplant

Terminated

• Conditions: Chronic Rejection in Lung Transplant; Cytokine Production in Bos Post Lung Transplant

• Registration Number: NCT00449332
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-03-16
• Study First Submitted QC: 2007-03-16
• Study First Posted: 2007-03-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cytokines, chemokines and T cell subsets associated with BOS	12/2013

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States