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NCT05050955 · ClinicalTrials.gov registry record
AlloSure Lung Assessment and Metagenomics Outcomes Study
A clinical trial of Lung Transplant; Complications and Lung Transplant Failure and Rejection, sponsored by CareDx.
- Active
- Registry status
- 550
- Enrollment target
- 20
- Study locations
NCT05050955: Active study of Lung Transplant; Complications and Lung Transplant Failure and Rejection, sponsored by CareDx.
NCT05050955 is a study of Lung Transplant; Complications and Lung Transplant Failure and Rejection that is active but no longer recruiting, run by CareDx. The registered enrollment target is 550 participants, above the 485-participant average among 6 other Lung Transplant; Complications trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05050955, a study of Lung Transplant; Complications and Lung Transplant Failure and Rejection, is active but no longer recruiting, sponsored by CareDx.
- ACTIVE NOT RECRUITING
- Registry status
- 550 participants
- Enrollment target
- 20
- Study locations
Study Summary
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic).
Primary Outcome
Diagnostic performance characteristics (sensitivity, specificity, PPV, NPV) of AlloSure Lung to detect acute lung allograft dysfunction (ALAD).
Conditions Studied
Study Locations (20)
New York
- NYU Langone Health - New York
- Columbia University Medical Center - New York
- Montefiore Medical Center - The Bronx
California
- Cedars Sinai Medical Center - Los Angeles
- University of California (UCSF) School of Medicine - San Francisco
Pennsylvania
- University of Pennsylvania - Philadelphia
- Temple University - Philadelphia
Alabama
- University of Alabama (UAB) - Birmingham
Arizona
- St. Joseph's Hospital & Medical Center - Phoenix
Colorado
- University of CO Anschutz Medical Campus - Aurora
Florida
- AdventHealth Orlando - Orlando
Illinois
- Loyola University Medical School - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2028-12-31 |
What the registry record for NCT05050955 still lists
NCT05050955 is an observational study that tracks outcomes without assigning an intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, above the 485-participant average among 6 other Lung Transplant; Complications trials with a reported enrollment target (13% higher).
The record links to 3 conditions, with Lung Transplant; Complications appearing as the primary indexed condition, and to 0 interventions.
NCT05050955 names 20 study sites across 16 states, led by New York, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05050955 about?
NCT05050955 is a clinical study titled "AlloSure Lung Assessment and Metagenomics Outcomes Study". ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of reject...
What is the current status of trial NCT05050955?
This trial is currently active not recruiting. The enrollment target is 550 participants. The study started on 2021-10-29. Estimated completion is 2028-12-31.
What conditions does trial NCT05050955 study?
This clinical trial studies the following conditions: Lung Transplant; Complications, Lung Transplant Failure and Rejection, Lung Transplant Infection.
Who is sponsoring clinical trial NCT05050955?
This trial is sponsored by CareDx, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05050955 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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