Long Term Follow up of the LTOG Cohort (LTOG)
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| ClinicalTrials.gov Identifier: NCT04787822 |
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Recruitment Status :
Enrolling by invitation
First Posted : March 9, 2021
Last Update Posted : May 6, 2022
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Sponsor:
University of Pennsylvania
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 | ||||||||||
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| 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 |
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| 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 |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: Plasma and buffy coat
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| 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 | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Enrolling by invitation | |||||||||
| Estimated Enrollment |
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
Long-term functional status and well-being
Exclusion Criteria Long-term phenotyping of CLAD
Long-term functional status and well-being
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| Sex/Gender |
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| 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 ) |
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| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| 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 |
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| Investigators |
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| PRS Account | University of Pennsylvania | |||||||||
| Verification Date | May 2022 | |||||||||