Lung Transplant Failure and Rejection, Lung Transplant Infection
Conditions
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. .
Interventions
DIAGNOSTIC_TESTcell-free dNA
Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients
Sponsors
Jesper Magnusson
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Contacts
Primary ContactJesper M Magnusson, MD, PhD
Outcome results
None listed