AlloSure Lung Assessment and Metagenomics Outcomes Study

Study Overview
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Brief Summary
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ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, AlloID™, iBox, HistoMap, and AlloHeme) 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.

Detailed Description
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This is a prospective, multicenter, observational registry of lung transplant recipients receiving LungCare (AlloSure-Lung, AlloMap Lung, AlloID, iBox, and Histomap, and AlloHeme) 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.

Official Title
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AlloSure Lung Assessment and Metagenomics Outcomes Study

Conditions
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Lung Transplant Infection, Lung Transplant; Complications, Lung Transplant Failure and Rejection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or Bilateral, deceased-donor, initial or re-transplant ≤ 90 days post-transplant Ability to understand and provide informed consent and adhere to laboratory surveillance schedule Patients who have LungCare initiated within 30 days of signing the informed consent form Exclusion Criteria: Multi-organ transplants Pregnancy Active malignancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LungCare Surveillance (1000 Cases)<br> | |
| Control Group (500 Controls)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An analysis of CLAD-free Lung Transplant Recipients (LTR). | An analysis of CLAD-free for Lung Transplant Recipients (LTR) who are clinically managed with routine surveillance protocol bronchoscopy procedures and those patients from centers who do not manage with standard of practice (SOP) protocol bronchoscopy/biopsy surveillance. LungCare testing will be performed on both LTR cohorts. The outcomes of this cohort will be compared to the control group that did not receive LungCare. | Patients must be enrolled by 3 months post-transplant. | 
| An analysis of severe Infection-free Survival for Lung Transplant Recipients (LTR) | An analysis of Severe Infection-free Survival for Lung Transplant Recipients (LTR) who are clinically managed with routine surveillance protocol bronchoscopy procedures and those patients from centers who do not manage with standard of practice (SOP) protocol bronchoscopy/biopsy surveillance. LungCare testing will be performed on both LTR cohorts. The outcomes of this cohort will be compared to the control group that did not receive LungCare. | Patients must be enrolled by 3 months post-transplant. |