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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung transplanted patients | All eligible patients were transplanted and followed up within the catchment area of the participating centre. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cell-free dNA | Diagnostic Test | Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Damage distinction | Null hypothesis: Levels of Cf-DNA is not different at samples taken with allograft damage and no allograft damage. | One month, three months, one year, three years, five years |
| Measure | Description | Time Frame |
|---|---|---|
| Damage detection Limit | 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. | One month, three months, one year, three years, five years |
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Inclusion Criteria:
A good understanding to read and write within the languages in which the consent is provided.
Exclusion Criteria:
No good understanding to read and write within the languages in which the consent is provided.
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Newly lung transplanted patients within scandinavia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesper M Magnusson, MD, PhD | Contact | +0463421000 | jesper.magnusson@gu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University hospital | Recruiting | Gothenburg | Västra Götaland County | 413 45 | Sweden |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000081182 | Noninvasive Prenatal Testing |
| ID | Term |
|---|---|
| D000073890 | Liquid Biopsy |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
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Cell free DNA
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D005820 | Genetic Testing |
| D013048 | Specimen Handling |
| D011296 | Prenatal Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |