AlloSure Lung Assessment and Metagenomics Outcomes Study (ALAMO)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Transplant; Complications; Lung Transplant Failure and Rejection; Lung Transplant Infection

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.

• Study Type: Observational
• Enrollment (Actual): 550

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama (UAB)
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital & Medical Center
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • San Francisco, California, United States, 94143
      • University of California (UCSF) School of Medicine
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of CO Anschutz Medical Campus
  • Florida
    • Orlando, Florida, United States, 32804
      • AdventHealth Orlando
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical School
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Health
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Mayland
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University-Barnes Jewish Hospital
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10027
      • Columbia University Medical Center
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • UT Health/ Memorial Hermann Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All lung transplant patients without exclusion criteria will be eligible to enter the study. Patients will be approached by the study team at the time of listing or at the time of transplant or within 90 days post-transplant to discuss the trial, consent and enrollment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
LungCare Surveillance (500 Cases); Observational evaluation of diagnostic performance characteristics of AlloSure Lung to detect a spectrum of rejection and allograft infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALAD	Diagnostic performance characteristics (sensitivity, specificity, PPV, NPV) of AlloSure Lung to detect acute lung allograft dysfunction (ALAD).	1 year post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic lung allograft dysfunction	Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect chronic lung allograft dysfunction.	3 years post-transplant
Acute cellular rejection	Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute cellular rejection (ACR).	3 years post-transplant
Antibody mediated rejection	Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect antibody mediated rejection (AMR).	3 years post-transplant
Acute infection	Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute infection.	3 years post-transplant
Subject Variability	Define within-subject and between-subject variability of AlloSure Lung in clinically stable patients in order to establish reference change value RCV.	3 years post-transplant
ALAD vs. Stability	Evaluate the diagnostic performance characteristics of utilizing RCV to distinguish ALAD vs. Stability	3 years post-transplant
Biopsy-proven rejections	The proportion of biopsy-proven rejections with elevated AlloSure Lung versus those without elevated AlloSure-Lung.	3 years post-transplant
AlloSure Lung Results	The proportion of AlloSure Lung results obtained as surveillance or for-cause, that the physicians felt influenced their decisions around management of patients.	3 years post-transplant
ALAD Free survival	ALAD free survival in lung transplant recipients who received AlloSure Lung as part of post-transplant surveillance.	3 years post-transplant
AlloSure Levels	Evaluate AlloSure levels 30-90 days prior to acute rejection.	3 years post-transplant

Collaborators and Investigators

• Sponsor: CareDx
• Investigators: Principal Investigator: Debbie Levine, Stanford University; Principal Investigator: Ciara Shaver, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Social Behavior; Rejection, Psychology
• Other Study ID Numbers: SN-C-00016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No