Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

Jesper Magnusson

Status: Enrolling

Conditions: Lung Transplant Infection; Lung Transplant Failure and Rejection

Treatments: Diagnostic Test: cell-free dNA

Study type: Observational

Funder types: Other

Identifiers

NCT06679257

LEONARDO

Details and patient eligibility

About

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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Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

146 participants in 1 patient group

Lung transplanted patients

Description:

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

Treatment:

Diagnostic Test: cell-free dNA