Liquid BiopsiEs for LuNg AllogRaft Damage ClassificatiOn - LEONARDO

Not yet recruiting

• Conditions: Lung Transplant Failure and Rejection; Lung Transplant Infection

• Registration Number: NCT06679257
• Lead Sponsor: Jesper Magnusson

Brief 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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Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• Study Start: 2024-12
• Primary Completion: 2029-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 146

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Damage distinction	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 Outcome Measures

Name	Time	Method
Damage detection Limit	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.