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NCT Number: NCT06679257

Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

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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Key information

Conditions

Lung Transplant Failure and Rejection Behavior Lung Transplant Infection Rejection, Psychology Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

Location status: Recruiting

Location contact

Jesper M Magnusson, MD, PhD

CONTACT

[email protected]

+046313421000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cell-free DNA

Diagnostic Test

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

Primary outcomes

  1. Damage distinction

    Time frame: One month, three months, one year, three years, five years

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

Secondary outcomes

  1. Damage detection Limit

    Time frame: One month, three months, one year, three years, five years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jesper M Magnusson, MD, PhD

CONTACT

[email protected]

+0463421000

Sponsors and collaborators

Lead sponsor

Jesper Magnusson

Other Gov

Registry information

Official study title

Liquid Biopsies for Lung Allograft Damage Classification

Acronym: LEONARDO

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Nov 7, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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