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A Registry to Evaluate the Performance of the BDX-XL2 Test

NCT03766958 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 842

Last updated 2024-05-24

No results posted yet for this study

Summary

The purpose of the ORACLE Registry is to demonstrate clinical utility of the BDX-XL2 test; specifically, the potential to reduce unnecessary invasive procedures, such as biopsies and surgeries, on benign lung nodules while not significantly increasing the number of malignant lung nodules routed to CT surveillance. Clinical data will be collected from participating patients to evaluate the impact of the BDX-XL2 test when used in the clinical management of recently identified lung nodules assessed to have a low to moderate risk of cancer.

Conditions

  • Nodule Solitary Pulmonary
  • NSCLC

Sponsors & Collaborators

  • Biodesix, Inc.

    lead INDUSTRY

Principal Investigators

  • Steve Springmeyer · Biodesix, Inc.

  • Michael Pritchett, DO · Pinehurst Medical Clinic

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2022-05-12
Completion
2024-05-23

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766958 on ClinicalTrials.gov