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Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules
NCT04171492 · View on ClinicalTrials.gov ↗
Study Summary
This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
Conditions Studied
Study Locations (20)
North Carolina
- The University of North Carolina — Chapel Hill
- Duke University — Durham
- Southeastern Research Center — Winston-Salem
South Carolina
- Ralph H Johnson VA Medical Center — Charleston
- Medical University of South Carolina — Charleston
- Prisma Health — Greenville
Connecticut
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess — Boston
New York
- Mount Sinai Health System — New York
- Northwell Health — New York
Ohio
- Cleveland Clinic — Cleveland
- The Ohio State University — Coulmbus
Colorado
- University of Colorado — Aurora
District of Columbia
- MedStar — Washington D.C.
Indiana
- Indiana University — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2026-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04171492
The ClinicalTrials.gov registry entry for NCT04171492 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biodesix, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Non-small Cell Carcinoma appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04171492 reports 20 study locations spanning 13 distinct geographic areas — top geographies include North Carolina, South Carolina, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04171492 about?
NCT04171492 is a clinical study titled "Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules". This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
What is the current status of trial NCT04171492?
This trial is currently active not recruiting. The enrollment target is 2,000 participants. The study started on 2020-12-18. Estimated completion is 2026-12.
What conditions does trial NCT04171492 study?
This clinical trial studies the following conditions: Non-small Cell Carcinoma, Nodule Solitary Pulmonary. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04171492?
This trial is sponsored by Biodesix, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04171492 being conducted?
This trial has 20 study locations across Colorado, Connecticut, District of Columbia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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