ALAMO: AlloSure Lung Assessment and Metagenomics Outcomes study is a prospective, multi-center, observational registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap Lung) for surveillance and for-cause post-transplant. This study aims to validate the clinical performance characteristics of AlloSure Lung as a surveillance tool for lung allograft health and investigate the clinical utility of AlloSure Lung for surveillance of the spectrum of rejection and infection events in concert with standard of practice (SOP) post-transplant medical care in a robust lung transplant population. In addition, the AlloMap Lung and HistoMap samples will be collected and used to develop the tests and evaluate their utility as molecular diagnostic tools for detection of allograft rejection and infection events.
Participants in this study provide samples for up to three years post transplant.
This is a CareDx study. Funding for this study is anticipated to run through 2028.
This study is closed for enrollment.
Study Procedures
Blood samples will be collected regularly post-transplant. This study will collect blood with these draws whenever possible, and will do study specific draws when not.
Collection timepoints are:
- Monthly for the first year post transplant
- Quarterly for years two and three post transplant
This study plans to collect information from participants electronic medical record.
Information collected includes:
- Medical and research records
- Visit dates
- Donor information
- Recipient pre-transplant information
- Race
- Gender
- Date of transplant
- Medical history
- Records about visits and physical exams
- Laboratory and other test results
- Medications
- Lung biopsy pathology reports
- Hospitalization/Clinically significant events