Lung Transplant; Complications, Lung Transplant Failure and Rejection, Lung Transplant Infection
Conditions
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.
Interventions
None listed
Sponsors
CareDx
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALAD | 1 year post-transplant | Diagnostic performance characteristics (sensitivity, specificity, PPV, NPV) of AlloSure Lung to detect acute lung allograft dysfunction (ALAD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic lung allograft dysfunction | 3 years post-transplant | Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect chronic lung allograft dysfunction. |
| Acute cellular rejection | 3 years post-transplant | Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute cellular rejection (ACR). |
| Antibody mediated rejection | 3 years post-transplant | Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect antibody mediated rejection (AMR). |
| Acute infection | 3 years post-transplant | Clinical diagnostic performance characteristics (sensitivity, specificity, PPV and NPV) of AlloSure Lung to detect acute infection. |
| Subject Variability | 3 years post-transplant | Define within-subject and between-subject variability of AlloSure Lung in clinically stable patients in order to establish reference change value RCV. |
| ALAD vs. Stability | 3 years post-transplant | Evaluate the diagnostic performance characteristics of utilizing RCV to distinguish ALAD vs. Stability |
| Biopsy-proven rejections | 3 years post-transplant | The proportion of biopsy-proven rejections with elevated AlloSure Lung versus those without elevated AlloSure-Lung. |
| AlloSure Lung Results | 3 years post-transplant | The proportion of AlloSure Lung results obtained as surveillance or for-cause, that the physicians felt influenced their decisions around management of patients. |
| ALAD Free survival | 3 years post-transplant | ALAD free survival in lung transplant recipients who received AlloSure Lung as part of post-transplant surveillance. |
| AlloSure Levels | 3 years post-transplant | Evaluate AlloSure levels 30-90 days prior to acute rejection. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORDebbie Levine
Stanford University
PRINCIPAL_INVESTIGATORCiara Shaver
Vanderbilt University
Outcome results
None listed