Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO
NCT ID: NCT06679257
Last Updated: 2025-09-16
Study Results
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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RECRUITING
146 participants
OBSERVATIONAL
2024-11-15
2030-12-31
Brief Summary
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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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Study Design
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COHORT
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
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
Eligibility Criteria
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Inclusion Criteria
A good understanding to read and write within the languages in which the consent is provided.
Exclusion Criteria
No good understanding to read and write within the languages in which the consent is provided.
18 Years
ALL
No
Sponsors
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Jesper Magnusson
OTHER_GOV
Responsible Party
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Jesper Magnusson
MD, PhD, Associate professor
Locations
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Sahlgrenska University hospital
Gothenburg, Västra Götaland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LEONARDO
Identifier Type: -
Identifier Source: org_study_id
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