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Enrolling by Invitation

NCT Number: NCT04787822

Long Term Follow up of the LTOG 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.

Enrolling by Invitation

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Key information

Conditions

Lung Transplant Failure and Rejection Behavior Rejection, Psychology Social Behavior

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Chronic Lung Allograft Dysfunction (CLAD) phenotyping

    Time frame: 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.

  2. Functional status phenotyping

    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

    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.

  3. Well being phenotyping-LT-VLA

    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

    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.

  4. Well being phenotyping-LT-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

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • 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

Registry information

Official study title

Long Term Follow up of the Lung Transplant Outcomes Group Cohort

Acronym: LTOG

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2021
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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