Clinical trial NCT04787822: Long Term Follow up of the LTOG Cohort
Official title: Long Term Follow up of the Lung Transplant Outcomes Group Cohort
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lung Transplant Failure and Rejection
Keywords: Chronic lung allograft dysfunction
Functional status
Lung transplantation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Columbia University
name: University of Alabama at Birmingham
name: Stanford University
name: Johns Hopkins University
name: University of Michigan
name: University of Pittsburgh
name: Duke University
name: Indiana University
name: University of California, San Francisco
First posted: 2021-03-09
Enrollment: 4000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chronic Lung Allograft Dysfunction (CLAD) phenotyping
timeFrame: From date of transplant to the development of CLAD, up to 25 years
measure: Functional status phenotyping
timeFrame: 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
measure: Well being phenotyping-LT-VLA
timeFrame: 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
measure: Well being phenotyping-LT-QOL
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jason Christie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Scott Palmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Jonathan Singer, MD
role: PRINCIPAL_INVESTIGATOR
References: