Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJesper Magnusson

About this trial

LTx has the shortest survival of all solid organ transplants. The complex and time-demanding diagnostics of allograft dysfunction are a significant reason for this.

The current study aims overarchingly to improve survival after lung transplantation (LTx) through precise and fast diagnostics. The specific aim is to develop direct-to-clinical implementation biomarkers for the most important aspects of long-term survival after LTx. An in-house-developed PCR-based cell-free-DNA methodology (cf-DNA) will be used for allograft damage and combined with specific other biomarkers to identify damage type. The current clinical golden standard for damage identification will be performed at every sampling instance.

The research will be a single-centre prospective observational cohort study. The control samples at all time points will consist of the samples without allograft damage. Blood will be drawn at fixed time points and clinical events. All analyses will be performed at a separate lab, blinded to the patient's status.

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Eligibility criteria

Qualifiers

Luing Transplanted and followed up within the reach of the study paricipating centres.

Disqualifiers

Not Lung Transplanted or not followed up within the reach of the study paricipating centres.

Trial design

Treatments tested in this trial

  • cell-free dNA

Treatment groups

146 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jesper Magnusson

Lead sponsor

Vastra Gotaland Region

Sponsor institution