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RecruitingNCT06679257LEONARDOUpdated Sep 16, 2025

Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

An observational study in Lung Transplant Failure and Rejection and Lung Transplant Infection, sponsored by Jesper Magnusson. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Jesper Magnusson · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
146
Ages
18 Years and older
Sex
All
01

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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02

Conditions studied

  • Lung Transplant Failure and Rejection
  • Lung Transplant Infection

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03

In context

Rejection, Psychology

50 studies on the registry are indexed under Rejection, Psychology; 27 are open to participants now.

This study's planned enrollment of 146 is below the median of 188 across 25 observational studies indexed under Rejection, Psychology.

Browse Rejection, Psychology studies →

Lead sponsor

This is the only study on the registry with Jesper Magnusson as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newly lung transplanted patients within scandinavia

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
146 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Lung transplanted patients

    All eligible patients were transplanted and followed up within the catchment area of the participating centre.

    Diagnostic Test: cell-free dNA

Interventions

  • Diagnostic testcell-free dNA

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Sahlgrenska University hospital
    Gothenburg, Västra Götaland County 413 45, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06679257
Lead sponsor
Jesper Magnusson
Responsible party
Jesper Magnusson (MD, PhD, Associate professor, Vastra Gotaland Region) — Sponsor-investigator
First posted
Nov 7, 2024
Start date
Nov 15, 2024
Primary completion
Dec 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 16, 2025

Study contacts

Jesper M Magnusson, MD, PhD
Contact
jesper.magnusson@gu.se
+0463421000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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