LAMBDA 002 (Lung Registry) Study

Running, not enrolling

Conditions studied: Lung Transplant Rejection

In brief

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

Key facts

Study ID

NCT05170425

Run by

Natera, Inc.

People needed

154

Starts

2022-11-04

Expected to finish

2027-05-01

Last updated by the study team

2025-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older at the time of enrollment.
• Underwent a first single or bilateral deceased-donor lung transplant. 3) Allograft was from a genetically different donor (e.g., not an identical twin).
• 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.

You may not qualify if…

• Patients are not eligible for the study if they meet any of the following criteria:
• 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.
• 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.

Where it is running

• 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 — St 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
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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