CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.
Study Overview
Brief Summary
Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.
Detailed Description
At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.
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
- •all lung transplant recipients > 18 years signed ICF (informed consent form)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.
Time Frame: up to 520 weeks
death
Secondary Outcomes
- Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation.(from transplantation till 72 hours after surgery)
Investigators
Therese Lapperre
Prof. Dr. Lapperre
University Hospital, Antwerp