Clinical trial NCT05050955: AlloSure Lung Assessment and Metagenomics Outcomes Study
Official title: AlloSure Lung Assessment and Metagenomics Outcomes Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplant Infection
Lung Transplant; Complications
Lung Transplant Failure and Rejection
Lead sponsor: CareDx
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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 outcomes:
measure: ALAD
timeFrame: 1 year post-transplant
Secondary outcomes:
measure: Chronic lung allograft dysfunction
timeFrame: 3 years post-transplant
measure: Acute cellular rejection
timeFrame: 3 years post-transplant
measure: Antibody mediated rejection
timeFrame: 3 years post-transplant
measure: Acute infection
timeFrame: 3 years post-transplant
measure: Subject Variability
timeFrame: 3 years post-transplant
measure: ALAD vs. Stability
timeFrame: 3 years post-transplant
measure: Biopsy-proven rejections
timeFrame: 3 years post-transplant
measure: AlloSure Lung Results
timeFrame: 3 years post-transplant
measure: ALAD Free survival
timeFrame: 3 years post-transplant
measure: AlloSure Levels
timeFrame: 3 years post-transplant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama (UAB)
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: University of California (UCSF) School of Medicine
state: California
city: Aurora
country: United States
facility: University of CO Anschutz Medical Campus
state: Colorado
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical School
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Health
state: Kentucky
city: Baltimore
country: United States
facility: University of Mayland
state: Maryland
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University-Barnes Jewish Hospital
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: UT Health/ Memorial Hermann Hospital
state: Texas
city: Falls Church
country: United States
facility: Inova
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Stanford University
name: Debbie Levine
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Nirmal Sharma
role: PRINCIPAL_INVESTIGATOR
References: