Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

ConditionsLung Transplant Failure and Rejection Lung Transplant Infection

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.

Eligibility criteria

This trial does not accept healthy volunteers

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 population

Newly lung transplanted patients within scandinavia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

cell-free dNA
Diagnostic test
Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients

Treatment groups

146 Participants

are divided into 1 treatment group

Group A: Lung transplanted patients1 intervention

Trial outcomes

Primary outcomes

Damage distinction

Null hypothesis: Levels of Cf-DNA is not different at samples taken with allograft damage and no allograft damage.

Time frame

One month, three months, one year, three years, five years

Secondary outcomes

Damage detection Limit

If the null hypothesis is disproven, measure optimal cut off for distincition beteween samples indicating damage and not indicating damage. Also distinction between different types of damage, finally if distinction is attainable trhough association wit other known biomarkers.

Time frame

One month, three months, one year, three years, five years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jesper Magnusson

Lead sponsor

Vastra Gotaland Region

Sponsor institution

Source ClinicalTrials.gov

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