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Sponsored by: |
University of Chicago |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00449332 |
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 |
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Chronic Rejection in Lung Transplant Cytokine Production in Bos Post Lung Transplant |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Role of Inflammatory and Fibroproliferative Cytokines in the Pathogenesis of Bronchiolitis Obliterans Syndrome-OP in Lung Transplant Recipients. |
lung tissues
Estimated Enrollment: | 120 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2012 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Post lung transplant patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Lourdes Norwick, BSN, RN | 773-834-8076 | lnorwick@medicine.bsd.uchicago.edu |
United States, Illinois | |
The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Lourdes Norwick, BSN, RN 773-834-8076 lnorwick@medicine.bsd.uchicago.edu | |
Principal Investigator: Sangeeta M Bhorade, MD |
Principal Investigator: | Sangeeta M Bhorade, MD | University of Chicago |
Responsible Party: | The University of Chicago Hospitals ( Sangeeta Bhorade ) |
Study ID Numbers: | 14516A |
Study First Received: | March 16, 2007 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00449332 |
Health Authority: | United States: Institutional Review Board |
Chronic rejection, lung transplant, cytokines, bos |
Lung Diseases, Obstructive Lung Diseases, Interstitial Respiratory Tract Diseases Lung Diseases |
Bronchiolitis Bronchitis Bronchiolitis Obliterans |
Bronchial Diseases |