Long-Term Follow-up for Lung Transplant Recipients
This study is observing people who have had lung transplants and previously participated in the Lung Transplant Outcomes Group (LTOG) studies. The main goal is to understand how lung transplant function changes over a long time, up to 25 years, especially looking at Chronic Lung Allograft Dysfunction (CLAD), which is when the transplanted lung doesn't work as well. Researchers will also track your overall health and well-being. This is an observational study, meaning no new treatments are being tested. It aims to gather more information from existing medical records and new assessments from about 4000 participants. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study following approximately 4000 participants who previously enrolled in LTOG cohort studies. It involves both looking back at past data and collecting new information over time.
- What's involved
- If you are alive and enroll in the longitudinal part, you would have follow-up data collected every 6 months. This includes reviewing your medical records, performing a Short Physical Performance Battery (SPPB) assessment, providing blood samples, and completing surveys.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from the date of transplant until the study ends, they withdraw, or are no longer seen at the participating center, for up to 25 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Long Term Follow up of the LTOG Cohort
At a glance
Conditions
NCT04787822
Where you'd take part
This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University
New York, New Yorkno site contact published
Duke University
Durham, North Carolinano site contact published
Indiana University
Indianapolis, Indianano site contact published
Johns Hopkins University
Baltimore, Marylandno site contact published
Stanford University
Stanford, Californiano site contact published
University of Alabama Birmingham
Birmingham, Alabamano site contact published
University of California San Francisco
San Francisco, Californiano site contact published
University of Michigan
Ann Arbor, Michiganno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- 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
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Chronic Lung Allograft Dysfunction (CLAD) phenotypingFrom 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 phenotypingFrom 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-VLAFrom 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-QOLFrom 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.