Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO (LEONARDO)

Liquid Biopsies for Lung Allograft Damage Classification

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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Study Overview

• Status: Recruiting
• Conditions: Lung Transplant Failure and Rejection; Lung Transplant Infection
• Intervention / Treatment: Diagnostic test: cell-free dNA

• Study Type: Observational
• Enrollment (Estimated): 146

Contacts and Locations

• Study Contact: Name: Jesper M Magnusson, MD, PhD; Phone Number: +0463421000; Email: jesper.magnusson@gu.se

Study Locations

• Sweden
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 413 45
      • Recruiting
      • Sahlgrenska University Hospital
      • Contact: Jesper M Magnusson, MD, PhD; Phone Number: +046313421000; Email: jesper.magusson@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Newly lung transplanted patients within scandinavia

Description

Inclusion Criteria:

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

A good understanding to read and write within the languages in which the consent is provided.

Exclusion Criteria:

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

No good understanding to read and write within the languages in which the consent is provided.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung transplanted patients; All eligible patients were transplanted and followed up within the catchment area of the participating centre.	Diagnostic test: cell-free dNA; Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Damage distinction	Null hypothesis: Levels of Cf-DNA is not different at samples taken with allograft damage and no allograft damage.	One month, three months, one year, three years, five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One month, three months, one year, three years, five years

Collaborators and Investigators

• Sponsor: Jesper Magnusson

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Social Behavior; Rejection, Psychology; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Biopsy; Cytodiagnosis; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Genetic Testing; Genetic Techniques; Genetic Services; Diagnostic Services; Diagnostic Techniques, Obstetrical and Gynecological; Liquid Biopsy; Prenatal Diagnosis; Noninvasive Prenatal Testing
• Other Study ID Numbers: LEONARDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No