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Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

NCT06679257 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 146

Last updated 2025-09-16

No results posted yet for this study

Summary

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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Conditions

  • Lung Transplant Failure and Rejection
  • Lung Transplant Infection

Interventions

DIAGNOSTIC_TEST

cell-free dNA

Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients

Sponsors & Collaborators

  • Jesper Magnusson

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06679257 on ClinicalTrials.gov