Long Term Follow up of the LTOG Cohort

N/AEnrolling By InvitationNCT04787822

University of Pennsylvania4,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

4,000

Conditions

Lung Transplant Failure and Rejection

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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

Locations (10)

University of Alabama Birmingham

Birmingham, Alabama, United States

University of California San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: From date of transplant to the development of CLAD, up to 25 years

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.

Time frame: 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

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.

Time frame: 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

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.

Time frame: 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

Data from ClinicalTrials.gov

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