Menu
Enrolling by invitation NCT04787822

Long Term Follow up of the LTOG Cohort

— Observational Lung Transplant Failure and Rejection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Transplant Failure and Rejection. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long Term Follow up of the Lung Transplant Outcomes Group Cohort

Overview

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.

Primary outcome measures

  • Chronic Lung Allograft Dysfunction (CLAD) phenotyping [Time frame: From date of transplant to the development of CLAD, up to 25 years]
  • 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]
  • 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]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 10 centers
  • University of Alabama Birmingham — Birmingham
  • University of California San Francisco — San Francisco
  • Stanford University — Stanford
  • Indiana University — Indianapolis
  • Johns Hopkins University — Baltimore
  • University of Michigan — Ann Arbor
  • Columbia University — New York
  • Duke University — Durham
  • … and 2 more centers

Identifiers

NCT: NCT04787822 · 834898 · U01HL145435

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗