NCT06679257

Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

Liquid Biopsies for Lung Allograft Damage Classification

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 146 (estimated)
• Sponsor: Jesper Magnusson · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. .

Conditions

• Lung Transplant Failure and Rejection
• Lung Transplant Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cell-free dNA	Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients

Timeline

• Start date: 2024-11-15
• Primary completion: 2029-12-01
• Completion: 2030-12-01
• First posted: 2024-11-07
• Last updated: 2025-09-16

Locations

1 site across 1 country: Sweden