NCT04171492

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Biodesix, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: —

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.

Detailed description

A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as \< 50% risk of cancer by Mayo risk prediction algorithm.

Conditions

• Nodule Solitary Pulmonary
• Non-small Cell Carcinoma

Timeline

• Start date: 2020-12-18
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2019-11-21
• Last updated: 2025-09-19

Locations

25 sites across 2 countries: United States, Canada