Lung Transplant Specimen Repository and Data Registry Protocol
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| First Received Date ICMJE | December 31, 2008 | ||||||||
| Last Updated Date | May 2, 2013 | ||||||||
| Start Date ICMJE | November 2005 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
data registry and lung tissue repository [ Time Frame: ongoing ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00816257 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Lung Transplant Specimen Repository and Data Registry Protocol | ||||||||
| Official Title ICMJE | Lung Transplant Specimen Repository and Data Registry Protocol | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: BAL specimen blood lung biopsy specimens |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | lung transplant recipients |
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| Condition ICMJE | Lung Transplantation | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00816257 | ||||||||
| Other Study ID Numbers ICMJE | 2005H0101 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Karen Wood, The Ohio State University | ||||||||
| Study Sponsor ICMJE | Karen Wood | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Ohio State University | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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