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).
Brief Title
AlloSure Lung Assessment and Metagenomics Outcomes Study
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
415-287-2300
Central Contact Email
bcasassa@caredx.com
Central Contact Role
Contact
Central Contact Phone
415-287-2300
Central Contact Email
syin@caredx.com
Completion Date
Completion Date Type
Estimated
Conditions
Lung Transplant Infection
Lung Transplant; Complications
Lung Transplant Failure and Rejection
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05050955
Org Class
Industry
Org Full Name
CareDx
Org Study Id
SN-C-00016
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
AlloSure Lung Assessment and Metagenomics Outcomes Study
Primary Outcomes
Outcome Description
Diagnostic performance characteristics (sensitivity, specificity, PPV, NPV) of AlloSure Lung to detect acute lung allograft dysfunction (ALAD).
Outcome Measure
ALAD
Outcome Time Frame
1 year post-transplant
Secondary Outcomes
Outcome Description
Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect chronic lung allograft dysfunction.
Outcome Time Frame
3 years post-transplant
Outcome Measure
Chronic lung allograft dysfunction
Outcome Description
Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute cellular rejection (ACR).
Outcome Time Frame
3 years post-transplant
Outcome Measure
Acute cellular rejection
Outcome Description
Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect antibody mediated rejection (AMR).
Outcome Time Frame
3 years post-transplant
Outcome Measure
Antibody mediated rejection
Outcome Description
Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute infection.
Outcome Time Frame
3 years post-transplant
Outcome Measure
Acute infection
Outcome Description
Define within-subject and between-subject variability of AlloSure Lung in clinically stable patients in order to establish reference change value RCV.
Outcome Time Frame
3 years post-transplant
Outcome Measure
Subject Variability
Outcome Description
Evaluate the diagnostic performance characteristics of utilizing RCV to distinguish ALAD vs. Stability
Outcome Time Frame
3 years post-transplant
Outcome Measure
ALAD vs. Stability
Outcome Description
The proportion of biopsy-proven rejections with elevated AlloSure Lung versus those without elevated AlloSure-Lung.
Outcome Time Frame
3 years post-transplant
Outcome Measure
Biopsy-proven rejections
Outcome Description
The proportion of AlloSure Lung results obtained as surveillance or for-cause, that the physicians felt influenced their decisions around management of patients.
Outcome Time Frame
3 years post-transplant
Outcome Measure
AlloSure Lung Results
Outcome Description
ALAD free survival in lung transplant recipients who received AlloSure Lung as part of post-transplant surveillance.
Outcome Time Frame
3 years post-transplant
Outcome Measure
ALAD Free survival
Outcome Description
Evaluate AlloSure levels 30-90 days prior to acute rejection.
Outcome Time Frame
3 years post-transplant
Outcome Measure
AlloSure Levels
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ali Mansour
Investigator Email
amansour@montefiore.org
Investigator Sponsor Organization
External
Study Department
Cardiovascular and Thoracic Surgery
Study Division
Vascular Surgery
MeSH Terms
REJECTION, PSYCHOLOGY
SOCIAL BEHAVIOR
BEHAVIOR