Long Term Follow up of the LTOG Cohort

NCT04787822 | Enrolling By Invitation DMC

• 2 other identifiers: 834898U01HL145435
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 10

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.

Conditions

Lung Transplant Failure and Rejection

Keywords

Chronic lung allograft dysfunction; Functional status; Lung transplantation

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Columbia University: collaborator
• University of Alabama at Birmingham: collaborator
• Stanford University: collaborator
• Johns Hopkins University: collaborator
• University of Michigan: collaborator
• University of Pittsburgh: collaborator
• Duke University: collaborator
• Indiana University: collaborator
• University of California, San Francisco: collaborator

Study Sites (10)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and buffy coat

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Jason Christie, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Scott Palmer, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Jonathan Singer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 9, 2021
• Study Start: June 15, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)