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

October 31, 2022 updated by: University of Colorado, Denver

A Longitudinal Study of Donor-Derived Cell Free DNA in Lung Transplant

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Consented adult lung transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

CareDx

Investigators

  • Principal Investigator: Alice L Gray, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2020

Primary Completion (Actual)

November 22, 2021

Study Completion (Actual)

November 22, 2021

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 19-2946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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