Lung Transplant Specimen Repository and Data Registry Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Wood, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00816257
First received: December 31, 2008
Last updated: November 18, 2013
Last verified: November 2013

December 31, 2008
November 18, 2013
November 2005
November 2013   (final data collection date for primary outcome measure)
data registry and lung tissue repository [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00816257 on ClinicalTrials.gov Archive Site
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Lung Transplant Specimen Repository and Data Registry Protocol
Lung Transplant Specimen Repository and Data Registry Protocol

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

BAL specimen blood lung biopsy specimens

Non-Probability Sample

lung transplant recipients

Lung Transplantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816257
2005H0101
No
Karen Wood, The Ohio State University
Karen Wood
Not Provided
Principal Investigator: David Nunley, MD Ohio State University
Ohio State University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP