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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05050955
Other study ID # SN-C-00016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 29, 2021
Est. completion date December 31, 2028

Study information

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

Clinical Trial Summary

ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCareâ„¢ (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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of CO Anschutz Medical Campus Aurora Colorado
United States University of Mayland Baltimore Maryland
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 Cedars Sinai Medical Center Los Angeles California
United States University of Louisville Health Louisville Kentucky
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
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