Long Term Follow up of the LTOG Cohort (LTOG)

Long Term Follow up of the Lung Transplant Outcomes Group Cohort

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Transplant Failure and Rejection

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Birmingham
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • Stanford, California, United States, 94305
      • Stanford University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • New York, New York, United States, 10027
      • Columbia University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Johns Hopkins University; National Heart, Lung, and Blood Institute (NHLBI); University of Alabama at Birmingham; Columbia University; University of Pittsburgh; University of Michigan; Duke University; University of California, San Francisco; Stanford University; Indiana University
• Investigators: Principal Investigator: Jason Christie, MD, University of Pennsylvania; Principal Investigator: Jonathan Singer, MD, University of California, San Francisco; Principal Investigator: Scott Palmer, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Functional status; Lung transplantation; Chronic lung allograft dysfunction
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Rejection, Psychology
• Other Study ID Numbers: 834898; U01HL145435 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No