Lung Transplant Specimen Repository and Data Registry Protocol

Completed

• Conditions: Lung Transplantation

• Registration Number: NCT00816257
• Lead Sponsor: Karen Wood

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.

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2008-12-31
• Study First Submitted QC: 2008-12-31
• Study First Posted: 2009-01-01
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
data registry and lung tissue repository	ongoing

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States