Early Indicators of Chronic Rejection in Lung Transplant (BOS)

September 19, 2016 updated by: University of Chicago

Role of Inflammatory and Fibroproliferative Cytokines in the Pathogenesis of Bronchiolitis Obliterans Syndrome-OP in Lung Transplant Recipients.

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.

Study Overview

Status

Terminated

Conditions

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

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Post lung transplant patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cytokines, chemokines and T cell subsets associated with BOS
Time Frame: 12/2013
12/2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Sangeeta M Bhorade, MD, University Of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14516A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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