Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cell-free dNA.
- Who it may be relevant to
- Registry conditions: Lung Transplant Failure and Rejection, Lung Transplant Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Liquid Biopsies for Lung Allograft Damage Classification
Overview
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. .
Interventions
- Diagnostic test cell-free dNA
Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients
Primary outcome measures
- Damage distinction [Time frame: One month, three months, one year, three years, five years]
Secondary outcome measures (1)
- Damage detection Limit [Time frame: One month, three months, one year, three years, five years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Sahlgrenska University hospital — Gothenburg
Identifiers
NCT: NCT06679257 · LEONARDO