Lung Transplant Failure and Rejection Clinical Trial
— LTOGOfficial title:
Long Term Follow up of the Lung Transplant Outcomes Group Cohort
Verified date | May 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of the study is to follow participants who enrolled in the Lung Transplant Outcomes Group. Clinical data, functional assessments, and surveys will be collected to determine long term graft function and functional status of lung transplant recipients.
Status | Enrolling by invitation |
Enrollment | 4000 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility | Inclusion criteria Long-term phenotyping of CLAD - Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers Long-term functional status and well-being - Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers - Alive Exclusion Criteria Long-term phenotyping of CLAD - Lung transplant recipient not enrolled in LTOG cohort research studies Long-term functional status and well-being - Lung transplant recipient not enrolled in the LTOG cohort research studies - Lung transplant recipient not receiving post-transplant follow-up care at a participating LTOG center |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Alabama Birmingham | Birmingham | Alabama |
United States | Duke University | Durham | North Carolina |
United States | Indiana University | Indianapolis | Indiana |
United States | Columbia University | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of California San Francisco | San Francisco | California |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Columbia University, Duke University, Indiana University, Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), Stanford University, University of Alabama at Birmingham, University of California, San Francisco, University of Michigan, University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chronic Lung Allograft Dysfunction (CLAD) phenotyping | Change in pulmonary function measured by serial pulmonary function tests (PFTs) and data collected at clinical care visits will be used to assess CLAD. | From date of transplant to the development of CLAD, up to 25 years | |
Primary | Functional status phenotyping | Change in functional status will be measured by the Short Physical Performance Battery (SPPB). The SPPB is a 3-construct measure that includes gait speed, chair stands, and balance. Each construct is scored from 0 - 4 yielding an aggregate score ranging from 0 - 12. Lower SPPB scores reflect increased frailty. | From date of transplant to until study termination, withdrawal, or no longer being seen for follow-up at the participating center, up to 25 years | |
Primary | Well being phenotyping-LT-VLA | Change in well being will be measured by patient reported outcomes including the LT-VLA scale. The LT-VLA scale presents a list of activities and asks respondents to rate their difficulty in performing each one on a 4-point scale. A higher score on the LT-VLA indicates more disability. | From date of transplant to until study termination, withdrawal, or no longer being seen for follow-up at the participating center, up to 25 years | |
Primary | Well being phenotyping-LT-QOL | Change in well being will be measured by patient reported outcomes including the Lung Transplant Quality of Life (LT-QOL) survey. The Lung Transplant Quality of Life (LT-QOL) survey will be used to measure disease specific QOL. The LT-QOL utilizes 5 point scales for all items. The general quality of life scale is scored so that higher scores indicate better QOL. | From date of transplant to until study termination, withdrawal, or no longer being seen for follow-up at the participating center, up to 25 years |
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