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Cell-free DNA as a Biomarker After Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04271267
Recruitment Status : Completed
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
CareDx
Information provided by (Responsible Party):
Duke University

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 transplant recipients.

Condition or disease Intervention/treatment
Lung Transplant Rejection Other: No Intervention

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Cell-free DNA in the Blood and Lung Allograft Fluid: Understanding Association With Acute Rejection in Lung Transplant Recipients
Actual Study Start Date : December 20, 2015
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acute Rejection Cohort
The subset of samples corresponding to biopsy-proven acute rejection
Other: No Intervention
Rejection-free Cohort
The subset of samples corresponding to a transbronchial biopsy free of acute cellular rejection.
Other: No Intervention



Primary Outcome Measures :
  1. Fraction dd-cfDNA, measured at the time of lung biopsy [ Time Frame: Within the first 6 months after lung transplantation ]
    The fraction of dd-cfDNA in plasma and BAL fluid measured at the time of concurrent clinical lung biopsy.


Secondary Outcome Measures :
  1. Fraction dd-cfDNA, measured at the time of PFT measurement. [ Time Frame: Within the first 6 months after lung transplantation ]
    The fraction of dd-cfDNA in plasma and BAL fluid measured at the time of concurrent clinical PFTs measurement.


Biospecimen Retention:   Samples With DNA
Isolated cfDNA from plasma and BAL samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CTOT-20 Study Population (Patient population for the current analyses came from within this overall population). Adult lung transplant recipients undergoing lung transplant at each of the participating centers were eligible.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271267


Sponsors and Collaborators
Duke University
CareDx
Investigators
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Principal Investigator: Scott Palmer, MD, MHS Duke University
Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04271267    
Other Study ID Numbers: Pro00078935
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Lung Transplantation
Acute Rejection
Cell-free DNA