AlloSure Lung Assessment and Metagenomics Outcomes Study

Lung Transplant; Complications Clinical Trial

— ALAMO  

Official title:

AlloSure Lung Assessment and Metagenomics Outcomes Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050955
• Other study ID #: SN-C-00016
• Status: Recruiting
• Start date: October 29, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: CareDx
• Contact: Brandie Casassa
• Phone: 415-287-2300
• Email: bcasassa[@]caredx.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 investigate the clinical utility of AlloSure®-Lung for surveillance of the spectrum of rejection and infection events in concert with standard of practice (SOP) post-transplant medical care in a robust lung transplant population. The AlloID™ metagenomics NGS plasma test will be collected and performed for research to validate this molecular diagnostic tool versus SOP microbiologic techniques for detection of allograft infection events.

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. Consecutive 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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of CO Anschutz Medical Campus	Aurora	Colorado
United States	University of Alabama (UAB)	Birmingham	Alabama
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Inova	Falls Church	Virginia
United States	UT Health/ Memorial Hermann Hospital	Houston	Texas
United States	Loyola University Medical School	Maywood	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Washington University-Barnes Jewish Hospital	Saint Louis	Missouri
United States	University of California (UCSF) School of Medicine	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
CareDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALAD	Diagnostic performance characteristics (sensitivity, specificity, PPV, NPV) of AlloSure Lung to detect acute lung allograft dysfunction (ALAD).	1 year post-transplant
Secondary	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
Secondary	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
Secondary	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
Secondary	Acute infection	Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute infection.	3 years post-transplant
Secondary	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
Secondary	ALAD vs. Stability	Evaluate the diagnostic performance characteristics of utilizing RCV to distinguish ALAD vs. Stability	3 years post-transplant
Secondary	Biopsy-proven rejections	The proportion of biopsy-proven rejections with elevated AlloSure Lung versus those without elevated AlloSure-Lung.	3 years post-transplant
Secondary	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
Secondary	ALAD Free survival	ALAD free survival in lung transplant recipients who received AlloSure Lung as part of post-transplant surveillance.	3 years post-transplant
Secondary	AlloSure Levels	Evaluate AlloSure levels 30-90 days prior to acute rejection.	3 years post-transplant