Long Term Follow up of the LTOG Cohort

Lung Transplant Failure and Rejection Clinical Trial

— LTOG  

Official title:

Long Term Follow up of the Lung Transplant Outcomes Group Cohort

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04787822
• Other study ID #: 834898
• Secondary ID: U01HL145435
• Status: Enrolling by invitation
• Start date: June 15, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lung Transplant Failure and Rejection

Locations

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

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

Outcome

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