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Long Term Follow up of the LTOG Cohort (LTOG)

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ClinicalTrials.gov Identifier: NCT04787822
Recruitment Status : Not yet recruiting
First Posted : March 9, 2021
Last Update Posted : March 26, 2021
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

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.

Condition or disease
Lung Transplant Failure and Rejection

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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Follow up of the Lung Transplant Outcomes Group Cohort
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : May 31, 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   Samples With DNA
Plasma and buffy coat


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04787822


Contacts
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Contact: Jason Christie, MD 215-662-6003 jason.christie@pennmedicine.upenn.edu
Contact: Michelle Oyster, MS 215-573-4767 oysterm@pennmedicine.upenn.edu

Locations
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United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Contact: Renita Holmes       rlholmes@uabmc.edu   
Principal Investigator: Keith Willie, MD         
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Contact: Gayelan Tietje-Ulrich    415-476-4539    Gayelan.Tietje-Ulrich@ucsf.edu   
Principal Investigator: Jonathan Singer, MD         
Stanford University
Stanford, California, United States, 94305
Contact: Gowri Vasudevan    650-736-8083    gowriv@stanford.edu   
Principal Investigator: Ann Weinacker, MD         
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Contact: Jean Nash, RN    317-962-0485    JNash3@IUHealth.org   
Principal Investigator: Chadi Hage, MD         
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Contact: Joby Mathew       jmathe27@jhmi.edu   
Principal Investigator: Pali Shah, MD         
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Mary Maliarik, PhD    734-615-8627    marymali@med.umich.edu   
Principal Investigator: Vibha Lama         
United States, New York
Columbia University
New York, New York, United States, 10027
Contact: Shreena Patel, LPN    212-305-5527    sp3646@cumc.columbia.edu   
Principal Investigator: Luke Benvenuto, MD         
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Contact: Courtney Frankel       courtney.frankel@duke.edu   
Principal Investigator: Laurie Snyder, MD         
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Michelle Oyster, MS    215-573-4767    oysterm@pennmedicine.upenn.edu   
Principal Investigator: Jason D. Christie, MD         
Sub-Investigator: Joshua M. Diamond, MD         
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ritchie Koshy, MD    412-802-8624    koshyrg@upmc.edu   
Principal Investigator: John McDyer, MD         
Sponsors and Collaborators
University of Pennsylvania
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
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Principal Investigator: Jason Christie, MD University of Pennsylvania
Principal Investigator: Scott Palmer, MD Duke University
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04787822    
Other Study ID Numbers: 834898
U01HL145435 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Chronic lung allograft dysfunction
Functional status
Lung transplantation