Liquid Biopsies for Lung Allograft Damage Classification
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Damage distinction
Study Overview
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.
.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Damage distinction
Time Frame: 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 Outcomes
- Damage detection Limit(One month, three months, one year, three years, five years)
Investigators
Jesper Magnusson
MD, PhD, Associate professor
Vastra Gotaland Region