AlloSure Lung Assessment and Metagenomics Outcomes Study
- Conditions
- Lung Transplant InfectionLung Transplant Failure and RejectionLung Transplant; Complications
- Registration Number
- NCT05050955
- Lead Sponsor
- CareDx
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- 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
- Multi-organ transplants
- Pregnancy
- Active malignancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALAD 1 year post-transplant Diagnostic performance characteristics (sensitivity, specificity, PPV, NPV) of AlloSure Lung to detect acute lung allograft dysfunction (ALAD).
- Secondary Outcome Measures
Name Time Method Biopsy-proven rejections 3 years post-transplant The proportion of biopsy-proven rejections with elevated AlloSure Lung versus those without elevated AlloSure-Lung.
Acute cellular rejection 3 years post-transplant Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute cellular rejection (ACR).
ALAD vs. Stability 3 years post-transplant Evaluate the diagnostic performance characteristics of utilizing RCV to distinguish ALAD vs. Stability
Antibody mediated rejection 3 years post-transplant Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect antibody mediated rejection (AMR).
Subject Variability 3 years post-transplant Define within-subject and between-subject variability of AlloSure Lung in clinically stable patients in order to establish reference change value RCV.
AlloSure Lung Results 3 years post-transplant The proportion of AlloSure Lung results obtained as surveillance or for-cause, that the physicians felt influenced their decisions around management of patients.
Chronic lung allograft dysfunction 3 years post-transplant Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect chronic lung allograft dysfunction.
ALAD Free survival 3 years post-transplant ALAD free survival in lung transplant recipients who received AlloSure Lung as part of post-transplant surveillance.
AlloSure Levels 3 years post-transplant Evaluate AlloSure levels 30-90 days prior to acute rejection.
Acute infection 3 years post-transplant Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute infection.
Trial Locations
- Locations (22)
University of Wisconsin Madison
🇺🇸Madison, Wisconsin, United States
University of Alabama (UAB)
🇺🇸Birmingham, Alabama, United States
St. Joseph's Hospital & Medical Center
🇺🇸Phoenix, Arizona, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California (UCSF) School of Medicine
🇺🇸San Francisco, California, United States
University of CO Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Loyola University Medical School
🇺🇸Maywood, Illinois, United States
University of Louisville Health
🇺🇸Louisville, Kentucky, United States
University of Mayland
🇺🇸Baltimore, Maryland, United States
Brigham and Womens Hospital
🇺🇸Boston, Massachusetts, United States
Washington University-Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
UT Health/ Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Inova
🇺🇸Falls Church, Virginia, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada