AlloSure Lung Assessment and Metagenomics Outcomes Study

NCT05050955 | Active Not Recruiting

• 1 other identifier: SN-C-00016
• Study Type: observational
• Target: 550
• Locations: 2 countries
• Sites: 22

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• ALAD

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

  1 year post-transplant

Secondary Outcomes (10)

• Chronic lung allograft dysfunction

  3 years post-transplant

• Acute cellular rejection

  3 years post-transplant

• Antibody mediated rejection

  3 years post-transplant

• Acute infection

  3 years post-transplant

• Subject Variability

  3 years post-transplant

Study Arms (1)

LungCare Surveillance (500 Cases)

Observational evaluation of diagnostic performance characteristics of AlloSure Lung to detect a spectrum of rejection and allograft infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Multi-organ transplants
• Pregnancy
• Active malignancy

Sponsors & Collaborators

• CareDx: lead

Study Sites (22)

University of Alabama (UAB)

Birmingham, Alabama, 35233, United States

Location

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California (UCSF) School of Medicine

San Francisco, California, 94143, United States

Location

University of CO Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Loyola University Medical School

Maywood, Illinois, 60153, United States

Location

University of Louisville Health

Louisville, Kentucky, 40202, United States

Location

University of Mayland

Baltimore, Maryland, 21201, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University-Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10027, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Health/ Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Inova

Falls Church, Virginia, 22042, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Debbie Levine

  Stanford University

  PRINCIPAL INVESTIGATOR

• Nirmal Sharma

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 21, 2021
• Study Start: October 29, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (21); CA (1)