AlloSure Lung Assessment and Metagenomics Outcomes Study

N/AActive Not RecruitingNCT05050955

CareDx550 enrolled

Overview

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 evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic).

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. 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.

Study Type

OBSERVATIONAL

Enrollment

550

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Unilateral or Bilateral, deceased-donor, initial or re-transplant 2. ≤ 90 days post-transplant 3. Ability to understand and provide informed consent and adhere to laboratory surveillance schedule 4. Patients who have LungCare initiated within 30 days of signing the informed consent form Exclusion Criteria: 1. Multi-organ transplants 2. Pregnancy 3. Active malignancy

Locations (22)

University of Alabama (UAB)

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

ALAD

Diagnostic performance characteristics (sensitivity, specificity, PPV, NPV) of AlloSure Lung to detect acute lung allograft dysfunction (ALAD).

Time frame: 1 year post-transplant

Secondary Outcomes

Chronic lung allograft dysfunction

Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect chronic lung allograft dysfunction.