Lung Transplant; Complications Clinical Trial
Official title:
AlloSure Lung Assessment and Metagenomics Outcomes Study
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap for surveillance post-transplant. This study aims to 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. The AlloID™ metagenomics NGS plasma test will be collected and performed for research to validate this molecular diagnostic tool versus SOP microbiologic techniques for detection of allograft infection events.
This is a prospective, multicenter, observational registry of lung transplant recipients receiving LungCare (AlloSure-Lung, AlloMap Lung, and Histomap) surveillance testing. Patients will be recruited based on utilization of surveillance testing with LungCare, as deemed appropriate for their care post-transplant. Consecutive patients deemed eligible for the study by their physician will be invited to participate during their usual care visit. Enrolled patients will receive evaluations and treatment for their lung transplant according to their health care provider and clinical practice at each study site. Treatment and follow-up visits will be determined by the treating physician. Information related to surveillance testing, selected clinical outcomes, and treatments received for managing the lung transplant recipients will be collected from medical records. The product Laboratory Services Guide(s) will be provided as a reference. Patient data (including diagnosis and biopsy outcomes) will be drawn from the patients' medical records. This data will be recorded by the site study personnel via a web-based electronic data collection (EDC) system every month. The study is designed to observe the clinical use of LungCare and patient outcomes in a cohort of lung transplant recipients managed with LungCare. This cohort design is selected because it is efficient and effective to evaluate the real-world robust performance of LungCare on patient management and outcomes that can be generalized to the intended use population. A well-designed observational cohort study that includes a large number of patients with long-term follow-up may provide robust results with several advantages, such as gathering data regarding sequence of events to assess causality; examining multiple outcomes for a given LungCare use; calculating rates of biopsy and rejection; and operational efficiency. ;
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