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The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospera | Device | Prosperaâ„¢ 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test | 3 years |
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Patients must meet all the following selection criteria to be eligible for the study:
Inclusion Criteria
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.
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Lung Transplantation Patient
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| Name | Affiliation | Role |
|---|---|---|
| David Ross, MD | Natera, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | California City | California | 90048 | United States | ||
| Northwestern Memorial Hospital |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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|
| Chicago |
| Illinois |
| 60611 |
| United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Corewell Health | Grand Rapids | Michigan | 49503 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |