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Lung Transplant Specimen Repository and Data Registry Protocol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816257
First Posted: January 1, 2009
Last Update Posted: November 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karen Wood, The Ohio State University
  Purpose
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
Lung Transplantation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Lung Transplant Specimen Repository and Data Registry Protocol

Resource links provided by NLM:


Further study details as provided by Karen Wood, The Ohio State University:

Primary Outcome Measures:
  • data registry and lung tissue repository [ Time Frame: ongoing ]

Biospecimen Retention:   Samples With DNA
BAL specimen blood lung biopsy specimens

Enrollment: 64
Study Start Date: November 2005
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
lung transplant recipients
Criteria

Inclusion Criteria:

  • recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816257


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Karen Wood
Investigators
Principal Investigator: David Nunley, MD Ohio State University
  More Information

Responsible Party: Karen Wood, Karen Wood M.D., The Ohio State University
ClinicalTrials.gov Identifier: NCT00816257     History of Changes
Other Study ID Numbers: 2005H0101
First Submitted: December 31, 2008
First Posted: January 1, 2009
Last Update Posted: November 20, 2013
Last Verified: November 2013

Keywords provided by Karen Wood, The Ohio State University:
lung tissue repository