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

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ClinicalTrials.gov Identifier: NCT04171492
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 25, 2022
Information provided by (Responsible Party):
Biodesix, Inc.

Brief 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.

Condition or disease
Nodule Solitary Pulmonary Non-small Cell Carcinoma

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2026

Open Label
Nodify XL2 results will be reported to the investigator and available to the subject.
Nodify XL2 results will not be available to the investigative site or subject.

Primary Outcome Measures :
  1. Lung Nodule Diagnosis [ Time Frame: Up to 24 months ]
    Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution

Biospecimen Retention:   Samples Without DNA
Nodify XL2 plasma sample

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Subjects with newly identified, solid lung nodule determined to be low-moderate risk of cancer.

Inclusion Criteria:

  1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
  2. Subject is > 40 years of age at the time of the discovery of the lung nodule of concern
  3. Subject's lung nodule of concern meets the following:

    • Was incidentally identified or detected during lung cancer screening
    • Is a solid nodule
    • Has maximal dimension of > 8mm and < 30mm
  4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
  5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less

Exclusion Criteria:

  1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern
  2. Nodule of concern is part-solid or Ground Glass Opacity (GGO)
  3. Prior diagnosis of lung cancer
  4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
  5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
  6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
  7. Any illness or factor that will inhibit compliance with study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171492

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Contact: Russell F Hudnall 360-801-1658 russell.hudnall@biodesix.com
Contact: Niki Givens niki.givens@biodesix.com

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Sponsors and Collaborators
Biodesix, Inc.
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Principal Investigator: Leona Hamrick, DHSc, PA-C Biodesix, Inc.
Principal Investigator: Gerard Silvestri, MD Medical University of South Carolina
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Responsible Party: Biodesix, Inc.
ClinicalTrials.gov Identifier: NCT04171492    
Other Study ID Numbers: BDX-CD-003
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No