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OpenTrials
Completed

NCT Number: NCT04234919

Longitudinal Study of 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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • CareDx

Registry information

Official study title

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

Acronym: LoSt

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 21, 2020
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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