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Clinical Trials in the USA / NCT05170425
Active, not recruiting Observational

LAMBDA 002 (Lung Registry) Study

NCT05170425 · tracked via the Priya Life Science USA tracker
Sponsor
Natera, Inc.
Phase
Observational
Started
2022-11-04
Last updated
2025-05-22

Condition(s) studied

Lung Transplant Rejection

Investigational drug(s) / intervention(s)

Prospera

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).

Study summary

The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Patients must meet all the following selection criteria to be eligible for the study: Inclusion Criteria 1. Age 18 or older at the time of enrollment. 2. Underwent a first single or bilateral deceased-donor lung transplant. 3) Allograft was from a genetically different donor (e.g., not an identical twin). 4\) Meets criteria for one of the two study cohorts: a) Cohort 1: i) Previously enrolled and randomized in LAMBDA 001 (TBBx surveillance or Prospera surveillance) AND ii) Enrolled at least 12 and up to 18 months post-transplant b) Cohort 2: i) Not previously randomized in LAMBDA 001 (may have been enrolled if randomization did not occur) AND ii) Enrolled less than or equal to 12 months post-transplant 5) Prospera testing is planned as part of routine post-transplant management. Exclusion Criteria Patients are not eligible for the study if they meet any of the following criteria: 1\) Recipient of multi-organ transplant at the time of lung transplant. 2) Prior recipient of any solid organ or hematopoietic (bone marrow or stem cell) transplant. 3\) Human immunodeficiency virus (HIV) infection. 4) Pregnant. 5) Ongoing testing with another allograft dd-cfDNA assessment test is planned. 6) Unwilling or unable to provide informed consent. 7) Unwilling or unable to comply with study procedures.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Cedars-Sinai Medical Center California City California
Northwestern Memorial Hospital Chicago Illinois
Johns Hopkins Hospital Baltimore Maryland
Corewell Health Grand Rapids Michigan
Washington University School of Medicine St Louis Missouri
Columbia University Irving Medical Center New York New York
Ohio State University Medical Center Columbus Ohio
UT Southwestern Medical Center Dallas Texas
Baylor College of Medicine Medical Center Houston Texas
Houston Methodist Hospital Houston Texas
University of Washington Seattle Washington

More Natera, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05170425 on ClinicalTrials.gov ↗ ← All trials in the USA