Long Term Follow up of the LTOG Cohort

• Conditions: Lung Transplant Failure and Rejection

• Registration Number: NCT04787822
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

This project will involve both retrospective and prospective data collection from participants enrolled in the LTOG cohort studies. We will perform long-term Chronic Lung Allograft Dysfunction (CLAD) phenotyping of lung transplant recipients who participated in the LTOG cohort studies utilizing data collected for routine clinical visits. Surviving lung transplant recipients who participated in the LTOG cohort studies will be recruited to enroll in the longitudinal portion of the project. The longitudinal component will include follow-up data collection at 6 month intervals while alive until study termination, study withdrawal, or no longer being seen for follow-up at the participating center. Follow-up data collection will include clinical data collected by study coordinators by reviewing medical records, functional assessment through administration of the Short Physical Performance Battery (SPPB), blood collection and surveys. Data from this project will be linked to data and samples collected during the LTOG cohort or ancillary studies.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-09
• Study Start: 2021-06-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic Lung Allograft Dysfunction (CLAD) phenotyping	From date of transplant to the development of CLAD, up to 25 years	Change in pulmonary function measured by serial pulmonary function tests (PFTs) and data collected at clinical care visits will be used to assess CLAD.
Functional status phenotyping	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	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.
Well being phenotyping-LT-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	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.
Well being phenotyping-LT-VLA	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	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.

Trial Locations

Locations (10)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Columbia University; 🇺🇸 New York, New York, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Stanford University; 🇺🇸 Stanford, California, United States