Long Term Follow up of the LTOG Cohort

NCT ID: NCT04787822

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2026-05-31

Brief Summary

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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

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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

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Lung Transplant Failure and Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Christie, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Scott Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Jonathan Singer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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U01HL145435

Identifier Type: NIH

Identifier Source: secondary_id

View Link

834898

Identifier Type: -

Identifier Source: org_study_id

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