🏛️ Verified NIH Record • Updated 2025-09-16

Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules (NCT04171492)

A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Biodesix, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Colorado — Aurora, Colorado

Age range: 40 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (25 Sites)

  • University of Colorado — Aurora, Colorado
  • Massachusetts General Hospital — Boston, Connecticut
  • Beth Israel Deaconess — Boston, Connecticut
  • MedStar — Washington D.C., District of Columbia
  • Indiana University — Indianapolis, Indiana
  • The Johns Hopkins University — Baltimore, Maryland
  • University of Michigan — Ann Arbor, Michigan
  • Mayo Clinic — Rochester, Minnesota
  • The Washington University — St Louis, Missouri
  • Mount Sinai Health System — New York, New York
  • Northwell Health — New York, New York
  • The University of North Carolina — Chapel Hill, North Carolina
  • Duke University — Durham, North Carolina
  • Southeastern Research Center — Winston-Salem, North Carolina
  • Cleveland Clinic — Cleveland, Ohio
  • The Ohio State University — Coulmbus, Ohio
  • The Oregon Clinic — Portland, Oregon
  • Ralph H Johnson VA Medical Center — Charleston, South Carolina
  • Medical University of South Carolina — Charleston, South Carolina
  • Prisma Health — Greenville, South Carolina
  • University of Texas Southwestern — Dallas, Texas
  • University of Texas Medical Branch — Galveston, Texas
  • Virginia Commonwealth University — Richmond, Virginia
  • University of Calgary — Calgary, Alberta
  • McGill University Health Centre — Montreal, Quebec

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗