Longitudinal Study of Cell Free DNA in Lung Transplant

Completed

• Conditions: Lung Transplant Rejection

• Registration Number: NCT04234919
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-21
• Study Start: 2020-03-19
• Primary Completion: 2021-11-22
• Study Completion: 2021-11-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship	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

Name	Time	Method
Quantitative Assessments	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).

Trial Locations

Locations (1)

University of Colorado, Denver; 🇺🇸 Aurora, Colorado, United States