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Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv8
  2. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 5 of 5 sitesv7 Show 1 more changeShow less
    • Site details revised at 5 of 5 sites
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Minor Primary completion date: Dec 1, 2026 to Jan 30, 2027 Completion date: Dec 1, 2027 to Apr 30, 2027v5 Show 1 more changeShow less
    • Completion date: Dec 1, 2027 to Apr 30, 2027
  5. Minor Study sites: 4 to 5v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Study sites: 1 to 4v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 1, 2024 to Oct 31, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Dec 1, 2024 to Oct 31, 2024
    • Site details revised
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial studies whether a biomarker platform, the Virtual Nodule Clinic, can be used for the management of lung (pulmonary) nodules that are not clearly non-cancerous (benign) or clearly cancerous (malignant) (indeterminate pulmonary nodules \[IPNs\]). The management of IPNs is based on estimating the likelihood that the observed nodule is malignant. Many things, such as age, smoking history, and current symptoms, are considered when making a prediction of the likelihood of malignancy. Radiographic imaging characteristics are also considered. Lung nodule management for IPNs can result in unnecessary invasive procedures for nodules that are ultimately determined to be benign, or potential delays in treatment when results of tests cannot be determined or are falsely negative. The Virtual Nodule Clinic is an artificial intelligence (AI) based imaging software within the electronic health record which makes certain that identified pulmonary nodules are screened by clinicians with expertise in nodule management. The Virtual Nodule Clinic also features an AI based radiomic prediction score which designates the likelihood that a pulmonary nodule is malignant. This may improve the ability to manage IPNs and lower unnecessary invasive procedures or treatment delays. Using the Virtual Nodule Clinic may work better for the management of IPNs.
Trial Details
NCT Number NCT06638398
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Lung Neoplasm
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov