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TerminatedNCT00449332BOSUpdated Sep 20, 2016

Early Indicators of Chronic Rejection in Lung Transplant

An observational study in Chronic Rejection in Lung Transplant and Cytokine Production in Bos Post Lung Transplant, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-20.

Sponsored by University of Chicago · Observational

Why this study was terminated
PI left University
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Chronic rejection, lung transplant, cytokines, bos
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In context

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. cytokines, chemokines and T cell subsets associated with BOS

    Time frame: 12/2013

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Study locations

1 site
  • The University of Chicago
    Chicago, Illinois 60637, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00449332
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Mar 20, 2007
Start date
Mar 2006
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Sep 20, 2016

Study contacts

Sangeeta M Bhorade, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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