Evaluating LungCare for lung transplant recipients
AlloSure Lung Assessment and Metagenomics Outcomes Study
CareDx · NCT05050955
This study is testing if a new monitoring system called LungCare can help lung transplant recipients detect rejection and infections better during their regular check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CareDx (industry) |
| Locations | 22 sites (Birmingham, Alabama and 21 other locations) |
| Trial ID | NCT05050955 on ClinicalTrials.gov |
What this trial studies
This observational study, known as ALAMO, is a prospective registry that focuses on lung transplant recipients who are undergoing surveillance testing with LungCare, which includes AlloSure-Lung, AlloMap Lung, and HistoMap. The study aims to assess the effectiveness of AlloSure Lung in detecting various types of rejection and infections in lung transplant patients. Participants will be recruited during routine care visits and will have their clinical outcomes and treatment data collected from medical records. The study's design allows for real-world evaluation of LungCare's performance in managing lung transplant recipients.
Who should consider this trial
Good fit: Ideal candidates for this study are lung transplant recipients who are within 90 days post-transplant and have initiated LungCare surveillance testing.
Not a fit: Patients who have undergone multi-organ transplants, are pregnant, or have active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the monitoring and management of lung transplant recipients, potentially reducing complications and improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using similar surveillance approaches for transplant recipients, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 21 other locations
- University of Alabama (UAB) — Birmingham, Alabama, United States (ACTIVE_NOT_RECRUITING)
- St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States (RECRUITING)
- Cedars Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
- University of California (UCSF) School of Medicine — San Francisco, California, United States (ACTIVE_NOT_RECRUITING)
- University of CO Anschutz Medical Campus — Aurora, Colorado, United States (ACTIVE_NOT_RECRUITING)
- AdventHealth Orlando — Orlando, Florida, United States (ACTIVE_NOT_RECRUITING)
- Loyola University Medical School — Maywood, Illinois, United States (ACTIVE_NOT_RECRUITING)
- University of Louisville Health — Louisville, Kentucky, United States (RECRUITING)
- University of Mayland — Baltimore, Maryland, United States (ACTIVE_NOT_RECRUITING)
- Brigham and Womens Hospital — Boston, Massachusetts, United States (RECRUITING)
- Washington University-Barnes Jewish Hospital — Saint Louis, Missouri, United States (RECRUITING)
- Montefiore Medical Center — Bronx, New York, United States (RECRUITING)
- NYU Langone Health — New York, New York, United States (RECRUITING)
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
- Ohio State University — Columbus, Ohio, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Temple University — Philadelphia, Pennsylvania, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
- UT Health/ Memorial Hermann Hospital — Houston, Texas, United States (RECRUITING)
- Inova — Falls Church, Virginia, United States (ACTIVE_NOT_RECRUITING)
- University of Wisconsin Madison — Madison, Wisconsin, United States (ENROLLING_BY_INVITATION)
- Toronto General Hospital — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Debbie Levine — Stanford University
- Study coordinator: Brandie Casassa
- Email: bcasassa@caredx.com
- Phone: 415-287-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Transplant Infection, Lung Transplant, Complications, Lung Transplant Failure and Rejection