Lung Transplant InfectionALAMONCT05050955

AlloSure Lung Assessment and Metagenomics Outcomes Study

An observational study of Lung Transplant Infection and Lung Transplant; Complications, run by CareDx at 22 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lung Transplant Infection, Lung Transplant; Complications, Lung Transplant Failure and Rejection
How many people: 550 participants
Where: 22 sitesin 2 countries
Study dates: 29 Oct 2021to 31 Dec 2028
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

Multi-organ transplants
Pregnancy
Active malignancy

Trial locations and contacts

22 sites in 2 countries.

Country

City, postcode or hospital

22 sites in 2 countries

United States21 sites

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

Other trials in United States

Canada1 site

Toronto General Hospital
Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Read the 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.

Conditions: Lung Transplant Infection, Lung Transplant; Complications, Lung Transplant Failure and Rejection
Medical subject headings: Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05050955
Study group	Role	What they receive
LungCare Surveillance (500 Cases)		Observational evaluation of diagnostic performance characteristics of AlloSure Lung to detect a spectrum of rejection and allograft infection.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

Chronic lung allograft dysfunction
Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect chronic lung allograft dysfunction.
Measured: 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).
Measured: 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).
Measured: 3 years post-transplant
Acute infection
Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute infection.
Measured: 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.
Measured: 3 years post-transplant
ALAD vs. Stability
Evaluate the diagnostic performance characteristics of utilizing RCV to distinguish ALAD vs. Stability
Measured: 3 years post-transplant
Biopsy-proven rejections
The proportion of biopsy-proven rejections with elevated AlloSure Lung versus those without elevated AlloSure-Lung.
Measured: 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.
Measured: 3 years post-transplant
ALAD Free survival
ALAD free survival in lung transplant recipients who received AlloSure Lung as part of post-transplant surveillance.
Measured: 3 years post-transplant
AlloSure Levels
Evaluate AlloSure levels 30-90 days prior to acute rejection.
Measured: 3 years post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 202131 Dec 2028

First posted21 Sep 2021
Study start29 Oct 2021
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung Transplant InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 550 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT05050955
Sponsor's protocol ID: SN-C-00016
Acronym: ALAMO
Status last verified: Jun 2026
First submitted: 30 Aug 2021
Last updated: 25 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Transplant Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AlloSure Lung Assessment and Metagenomics Outcomes Study
ClinicalTrials.gov ID: NCT05050955
Acronym / sponsor ID: ALAMO / SN-C-00016
Conditions: Lung Transplant Infection, Lung Transplant; Complications, Lung Transplant Failure and Rejection
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 550 participants (actual)
Lead sponsor: CareDxIndustry (pharma, biotech, devices)
Study start: 29 Oct 2021 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 21 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 1

Arm	Type	Receives
LungCare Surveillance (500 Cases)	–	–Observational evaluation of diagnostic performance characteristics of AlloSure Lung to detect a spectrum of rejection and allograft infection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Multi-organ transplants
Pregnancy
Active malignancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

10 secondary outcomes

Chronic lung allograft dysfunction
Time frame: 3 years post-transplant
Acute cellular rejection
Time frame: 3 years post-transplant
Antibody mediated rejection
Time frame: 3 years post-transplant
Acute infection
Time frame: 3 years post-transplant
Subject Variability
Time frame: 3 years post-transplant
ALAD vs. Stability
Time frame: 3 years post-transplant
Biopsy-proven rejections
Time frame: 3 years post-transplant
AlloSure Lung Results
Time frame: 3 years post-transplant
ALAD Free survival
Time frame: 3 years post-transplant
AlloSure Levels
Time frame: 3 years post-transplant

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.

Related trials for Lung Transplant Infection

Active, not recruitingPhase 3
RSV Vaccine in Transplant Recipients
Vaccine Response Impaired, Respiratory Syncytial Virus Infections
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
RecruitingPhase 2
High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
Immunization; Infection|Transplantation Infection|Influenza, Influenza
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Debbie Levine principal investigator

Stanford University

Ciara Shaver principal investigator

Vanderbilt University

22 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplant Infection and Lung Transplant; Complications, run by CareDx at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ALAD (time frame: 1 year post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05050955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.