Status:
COMPLETED
Cell-free DNA as a Biomarker After Lung Transplantation
Lead Sponsor:
Duke University
Collaborating Sponsors:
CareDx
Conditions:
Lung Transplant Rejection
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this investigation is to determine the association of the fraction of donor-derived cell-free DNA in plasma and lung fluid samples with acute rejection as proven by biopsy in lung trans...
Detailed Description
Chronic lung disease is the third leading cause of death in the United States. Lung transplantation is an effective short-term intervention for select patients with advanced lung disease. Nearly 4,000...
Eligibility Criteria
Inclusion
- Subject must be able to understand and provide written informed consent and
- Must be ≥18 years of age at the time of written informed consent.
- Anticipated listing for lung transplantation OR within 45 days of having received a single or bilateral cadaveric donor lung transplant.
- Enrollment must occur prior to the start of bronchoscopies eligible for research bronchoalveolar lavage (BAL) sampling.
- Undergoing first lung transplant operation.
- Transplant surgery to be performed or performed at enrolling center. Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.
Exclusion
- Multi-organ recipient.
- Prior recipients of any solid organ transplant, including prior lung transplant.
- Prior or concurrent recipient of bone marrow transplant.
- HIV infection.
- Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.
- Participation in an investigational drug trial at the time of enrollment visit.
Key Trial Info
Start Date :
December 20 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04271267
Start Date
December 20 2015
End Date
November 30 2019
Last Update
February 17 2020
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