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Long Term Follow up of the LTOG Cohort (LTOG)

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ClinicalTrials.gov Identifier: NCT04787822
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2021
Last Update Posted : May 6, 2022
Sponsor:
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
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date February 22, 2021
First Posted Date March 9, 2021
Last Update Posted Date May 6, 2022
Actual Study Start Date June 15, 2021
Estimated Primary Completion Date May 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2021)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Follow up of the LTOG Cohort
Official Title Long Term Follow up of the Lung Transplant Outcomes Group Cohort
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma and buffy coat
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.
Condition Lung Transplant Failure and Rejection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: March 4, 2021)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2026
Estimated Primary Completion Date May 31, 2026   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04787822
Other Study ID Numbers 834898
U01HL145435 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party University of Pennsylvania
Original Responsible Party Same as current
Current Study Sponsor University of Pennsylvania
Original Study Sponsor Same as current
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
Investigators
Principal Investigator: Jason Christie, MD University of Pennsylvania
Principal Investigator: Scott Palmer, MD Duke University
Principal Investigator: Jonathan Singer, MD University of California, San Francisco
PRS Account University of Pennsylvania
Verification Date May 2022