Early Indicators of Chronic Rejection in Lung Transplant (BOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00449332
First received: March 16, 2007
Last updated: September 4, 2013
Last verified: December 2012
  Purpose

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
Chronic Rejection in Lung Transplant
Cytokine Production in Bos Post Lung Transplant

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • cytokines, chemokines and T cell subsets associated with BOS [ Time Frame: 12/2013 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

lung tissues, bal, blood


Estimated Enrollment: 120
Study Start Date: March 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Post lung transplant patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449332

Contacts
Contact: Lourdes Norwick, BSN, RN 773-834-8076 lnorwick@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Laura Krupa    773-834-8903    lkrupa@medicine.bsd.uchicago.edu   
Principal Investigator: Sangeeta M Bhorade, MD         
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         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Sangeeta M Bhorade, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00449332     History of Changes
Other Study ID Numbers: 14516A
Study First Received: March 16, 2007
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014