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Longitudinal Study of Cell Free DNA in Lung Transplant (LoSt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04234919
Recruitment Status : Enrolling by invitation
First Posted : January 21, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
CareDx
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Lung transplant is a viable treatment strategy for many with end-stage lung diseases. Despite advances in both the surgical and medical management, lung transplant recipients experience episodes of allograft insult and injury that lead to dysfunction and ultimately contribute to graft failure. The primary noninvasive tool for monitoring the lung allograft, pulmonary function testing, is neither sensitive nor specific for lung allograft injury which makes the management of lung transplant recipients particularly challenging. A decline in pulmonary function tests prompts invasive procedures such as bronchoscopy with transbronchial lung biopsy to diagnose the cause of allograft injury, although this, too, is not 100% sensitive, and oftentimes patients are treated empirically for rejection when no other etiology for lung function decline is identified. Empiric treatment prompted by extrapulmonary drivers of decline in lung function may result in inappropriate exposure to risks of augmented immunosuppression. The purpose of this study is to determine to what extent monitoring of donor-derived cell free DNA in lung transplant recipients can be used as a marker of lung injury and stability.

Condition or disease
Lung Transplant Rejection

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of Donor-Derived Cell Free DNA in Lung Transplant
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Consented adult lung transplant recipients



Primary Outcome Measures :
  1. Relationship [ Time Frame: 12 Months ]
    Determine the relationship between donor derived cell free DNA and lung allograft function during the first year after lung transplant.


Secondary Outcome Measures :
  1. Quantitative Assessments [ Time Frame: 12 Months ]
    Quantitative assessments of dd-cfDNA obtained at pre-specified timepoints post-transplant compared to clinical events (PGD scores, detection of allograft dysfunction, rejection, or infection).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with end stage lung disease who are placed on the lung transplant waitlist for consideration of a bilateral transplant at the University of Colorado lung transplant program will be recruited for participation in the study.
Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • Actively listed or have recently had a double lung transplant
  • Participant is willing and able to provide informed consent

Exclusion Criteria:

  • Prior organ transplantation
  • Transplantation performed in the setting of hospitalization for acute illness or decompensation
  • Unable or unwilling to consent for enrolment
  • Single lung transplant recipient
  • Consideration for multi-organ transplantation
  • Pregnant women

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): NCT04234919


Locations
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United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
CareDx
Investigators
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Principal Investigator: Alice L Gray, MD University of Colorado, Denver
Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04234919    
Other Study ID Numbers: 19-2946
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
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