LAMBDA 002 (Lung Registry) Study
- Conditions
- Lung Transplant Rejection
- Registration Number
- NCT05170425
- Lead Sponsor
- Natera, Inc.
- Brief Summary
The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.
- Detailed Description
The LAMBDA 002 registry study is an observational, longitudinal, multicenter study observing patients undergoing lung transplant in one of the following two cohorts:
Cohort 1: Previously enrolled and randomized in LAMBDA 001 (transbronchial biopsy surveillance or Prospera surveillance) and enrolled at least 12 and up to 18 months post-transplant.
Cohort 2: Not previously randomized in LAMBDA 001 (may have been enrolled but randomization did not occur), Prospera testing is part of clinical care and enrolled during less than or equal to 12 months posttransplant.
Primary Objective:
The primary objective of the study is to assess the clinical utility of combining Prospera testing with routine transplant management in detecting acute rejection or infection events in patients receiving Prospera testing as part of their post-transplant clinical care.
Secondary Objectives:
The secondary objectives of the study are to:
1. Determine whether Prospera can detect AR (acute rejection) and/or infection earlier than standard clinical indicators used concurrently during the study.
2. Evaluate Prospera's ability to differentiate between rejection and infectious injuries for single and repeat episodes of bacterial, viral, mycobacterial and fungal infections.
3. Evaluate changes in Prospera dd-cfDNA as an indicator for biopsy proven acute rejection (BPAR), graft failure, death, development of donor-specific antibodies (DSA), chronic lung allograft dysfunction (CLAD), infection episodes and response to treatment for rejection.
4. Evaluate changes in Prospera dd-cfDNA in assessments involving standard management for acute rejection and infection events.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 154
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Cedars-Sinai Medical Center
🇺🇸California City, California, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Baylor College of Medicine Medical Center
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Scroll for more (1 remaining)Cedars-Sinai Medical Center🇺🇸California City, California, United States