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

Study acronym: ALTITUDE
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 19, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv11
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 26 to 25
    v10
  3. Primary completion date: Dec 2024 to Dec 2025
    • Site details revised at 2 of 26 sites
    v9
  4. Study sites: 25 to 26v8
  5. Study sites: 24 to 25v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Dec 2022 to Dec 2024v6 Show 4 more changesShow less
    • Study sites: 17 to 24
    • Study completion date: Dec 2024 to Dec 2026
    • Eligibility criteria revised
    • Study description shortened, about 1 word
  2. Study sites: 2 to 17v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Oct 2021 to Dec 2022
    • Study sites: 0 to 2
    • Study completion date: Oct 2023 to Dec 2024
    • Start date changed from estimate of Sep 2020 to Dec 18, 2020
  4. Start date: May 2020 to Sep 2020
    • Primary completion date: May 2021 to Oct 2021
    • Study completion date: Dec 2022 to Oct 2023
    v3
  5. Start date: Jan 2020 to May 2020
    • Primary completion date: Jan 2021 to May 2021
    • Study completion date: Jul 2022 to Dec 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04171492
Lead Sponsor Biodesix, Inc.
Conditions
(from sponsor)		 Nodule Solitary Pulmonary, Non-small Cell Carcinoma
Related terms Solitary Pulmonary Nodule
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov