Clincosm LogoSign in Get a demo

Lung Transplant Specimen Repository and Data Registry Protocol

Sponsor
Karen Wood (Other)
Overall Status
Completed
CT.gov ID
NCT00816257
Collaborator
(none)
64
Enrollment
1
Location
96
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

All patients enrolled in the registry will be recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts). During the routine management of lung recipients frequent surveillance of the lung allograft is necessary. This routinely involves: measurement of pulmonary functions, chest radiography, collection of peripheral blood to assess other organ function and monitor therapeutic drug levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung tissue biopsy. This surveillance normally follows a set schedule during the first one to two years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8, 12, 24, 36, and 52 during the first year following the transplant procedure. Additional surveillance may be performed at any time when clinically indicated for the optimal management of the recipient. Information and specimens collected from each of these encounters will be entered in the data registry and specimen repository.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The collection of disposable lung allograft (transplant tissue samples), blood samples and information from medical records for storage, future analysis and research. Stored samples will be available to other researchers who have obtained separate review and approval from an ethics committee called an Institutional Review Board.

    Immediately prior to the transplant surgery, the surgeon or pulmonologist will routinely examine the lungs via bronchoscopy during which subjects will be medicated for pain.

    The samples that are obtained during this and post-surgery (clinically scheduled) bronchoscopies, including bronchial lavage, are either sent to pathology or are discarded if they do not qualify to go to pathology. For this research, the researchers are asking that the samples that do not qualify for pathology be placed into the repository instead of being thrown away.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    64 participants
    Time Perspective:
    Prospective
    Official Title:
    Lung Transplant Specimen Repository and Data Registry Protocol
    Study Start Date :
    Nov 1, 2005
    Actual Primary Completion Date :
    Nov 1, 2013
    Actual Study Completion Date :
    Nov 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. data registry and lung tissue repository [ongoing]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Karen Wood

    Investigators

    • Principal Investigator: David Nunley, MD, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Wood, Karen Wood M.D., Ohio State University
    ClinicalTrials.gov Identifier:
    NCT00816257
    Other Study ID Numbers:
    • 2005H0101
    First Posted:
    Jan 1, 2009
    Last Update Posted:
    Nov 20, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Karen Wood, Karen Wood M.D., Ohio State University
    lung tissue repository

    Study Results

    No Results Posted as of Nov 20, 2013