RecruitingNCT06679257

Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

Liquid Biopsies for Lung Allograft Damage Classification


Sponsor

Jesper Magnusson

Enrollment

146 participants

Start Date

Nov 15, 2024

Study Type

OBSERVATIONAL

Conditions

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. .


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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.

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Interventions

DIAGNOSTIC_TESTcell-free dNA

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


Locations(1)

Sahlgrenska University hospital

Gothenburg, Västra Götaland County, Sweden

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NCT06679257


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