Longitudinal Study of Cell Free DNA in Lung Transplant

NCT ID: NCT04234919

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-19
• Study Completion Date: 2021-11-22

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.

Conditions

Lung Transplant Rejection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Consented adult lung transplant recipients

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CareDx

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice L Gray, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado, Denver

Aurora, Colorado, United States

Countries

United States

References

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Other Identifiers

19-2946

Identifier Type: -

Identifier Source: org_study_id