AlloSure Lung Assessment and Metagenomics Outcomes Study

NCT05050955 · tracked via the Priya Life Science USA tracker

Sponsor

CareDx

Phase

Observational

Started

2021-10-29

Last updated

2026-06-25

Condition(s) studied

Lung Transplant InfectionLung Transplant; ComplicationsLung Transplant Failure and Rejection

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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

Trial sites (22)

Facility	City	Region
University of Alabama (UAB)	Birmingham	Alabama
St. Joseph's Hospital & Medical Center	Phoenix	Arizona
Cedars Sinai Medical Center	Los Angeles	California
University of California (UCSF) School of Medicine	San Francisco	California
University of CO Anschutz Medical Campus	Aurora	Colorado
AdventHealth Orlando	Orlando	Florida
Loyola University Medical School	Maywood	Illinois
University of Louisville Health	Louisville	Kentucky
University of Mayland	Baltimore	Maryland
Brigham and Womens Hospital	Boston	Massachusetts
Washington University-Barnes Jewish Hospital	St Louis	Missouri
NYU Langone Health	New York	New York
Columbia University Medical Center	New York	New York
Montefiore Medical Center	The Bronx	New York
Ohio State University	Columbus	Ohio
University of Pennsylvania	Philadelphia	Pennsylvania
Temple University	Philadelphia	Pennsylvania
Vanderbilt University Medical Center	Nashville	Tennessee
UT Health/ Memorial Hermann Hospital	Houston	Texas
Inova	Falls Church	Virginia
University of Wisconsin Madison	Madison	Wisconsin
Toronto General Hospital	Toronto	Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05050955 on ClinicalTrials.gov ↗ ← All trials in the USA