Lung Transplant Failure and RejectionLTOGNCT04787822
Long Term Follow up of the LTOG Cohort
An observational study of Lung Transplant Failure and Rejection, run by University of Pennsylvania at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Lung Transplant Failure and Rejection
- How many people
- 4,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Jun 2021to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama Birmingham
Birmingham, Alabama, 35294
Duke University
Durham, North Carolina, 27710
Indiana University
Indianapolis, Indiana, 46202
Columbia University
New York, New York, 10027
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California San Francisco
San Francisco, California, 94143
Stanford University
Stanford, California, 94305
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Transplant Failure and Rejection
- Keywords
- Chronic lung allograft dysfunction, Functional status, Lung transplantation
- Medical subject headings
- Rejection, Psychology
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start15 Jun 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Columbia University, University of Alabama at Birmingham, Stanford University, Johns Hopkins University, University of Michigan, University of Pittsburgh, Duke University, Indiana University, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Jason Christie, MD, Principal investigator, University of PennsylvaniaScott Palmer, MD, Principal investigator, Duke UniversityJonathan Singer, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787822
- Sponsor's protocol ID
- 834898
- Other IDs
- U01HL145435
- Acronym
- LTOG
- Status last verified
- Jun 2026
- First submitted
- 22 Feb 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of the Lung Transplant Outcomes Group Cohort
- ClinicalTrials.gov ID
- NCT04787822
- Acronym / sponsor ID
- LTOG / 834898
- Conditions
- Lung Transplant Failure and Rejection
- Keywords
- Chronic lung allograft dysfunction, Functional status, Lung transplantation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Columbia University, University of Alabama at Birmingham, Stanford University, Johns Hopkins University, University of Michigan, University of Pittsburgh, Duke University, Indiana University, University of California, San Francisco
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Christie, MD principal investigator
University of Pennsylvania
Scott Palmer, MD principal investigator
Duke University
Jonathan Singer, MD principal investigator
University of California, San Francisco
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Failure and Rejection, run by University of Pennsylvania at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Lung Allograft Dysfunction (CLAD) phenotyping (time frame: From date of transplant to the development of CLAD, up to 25 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.