Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

NCT ID: NCT06679257

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2030-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Lung Transplant Failure and Rejection Lung Transplant Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung transplanted patients

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

cell-free dNA

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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cell-free dNA

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jesper Magnusson

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jesper Magnusson

MD, PhD, Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sahlgrenska University hospital

Gothenburg, Västra Götaland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Jesper M Magnusson, MD, PhD

Role: CONTACT

+0463421000

Facility Contacts

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Jesper M Magnusson, MD, PhD

Role: primary

+046313421000

Other Identifiers

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LEONARDO

Identifier Type: -

Identifier Source: org_study_id

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