LAMBDA 002 (Lung Registry) Study

NCT05170425 | Active Not Recruiting

• 1 other identifier: 21-055-TRP
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Lung Transplant Rejection

Keywords

Prospera; Lung Transplant; Rejection

Outcome Measures

Primary Outcomes (1)

• Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test

  3 years

Study Arms (2)

Cohort 1

1\) Cohort 1: Previously enrolled AND randomized in LAMBDA 001 Participants enrolled to Cohort 1 will be enrolled at least 12 and up to 18 months post-transplant.

Device: Prospera

Cohort 2

2\) Cohort 2: Not previously randomized in LAMBDA 001 Participants who were enrolled in LAMBDA 001 but who were not randomized in LAMBDA 001 may be enrolled to Cohort 2.

Device: Prospera

Interventions

Prospera DEVICE

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).

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung Transplantation Patient

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.

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (11)

Cedars-Sinai Medical Center

California City, California, 90048, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• David Ross, MD

  Natera, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 28, 2021
• Study Start: November 4, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (11)