NCT05170425

LAMBDA 002 (Lung Registry) Study

Observational Registry Study With Sub-analysis (Patients Previously Randomized to LAMBDA 001) to Assess ProsperaTM Performance for Detection of CLAD After Lung Transplant (LAMBDA 002)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 154 (actual)
• Sponsor: Natera, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Transplant Rejection

Interventions

Type	Name	Description
DEVICE	Prospera	Prospera™ detects allograft rejection noninvasively and with high accuracy by measuring the fraction of donor derived cell-free DNA (dd-cfDNA) in the patient's blood, without the need for prior donor or recipient genotyping. Prospera is a commercially available Laboratory Developed Test (LDT) certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).

Timeline

• Start date: 2022-11-04
• Primary completion: 2026-08-01
• Completion: 2027-05-01
• First posted: 2021-12-28
• Last updated: 2025-05-22

Locations

11 sites across 1 country: United States