Lung Transplant Specimen Repository and Data Registry Protocol

NCT00816257 | Completed

• 1 other identifier: 2005H0101
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation

Keywords

lung tissue repository

Outcome Measures

Primary Outcomes (1)

• data registry and lung tissue repository

  ongoing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

lung transplant recipients

You may qualify if:

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

Sponsors & Collaborators

• Karen Wood: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

BAL specimen blood lung biopsy specimens

Study Officials

• David Nunley, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Karen Wood M.D.

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Start: November 1, 2005
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

US (1)