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

Non-small Cell Carcinoma Clinical Trial

— ALTITUDE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171492
• Other study ID #: BDX-CD-003
• Status: Recruiting
• Start date: December 18, 2020
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Biodesix, Inc.
• Contact: Niki Givens
• Phone: 7204951583
• Email: niki.givens[@]biodesix.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nodule Solitary Pulmonary
• Non-small Cell Carcinoma

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	McGill University Health Centre	Montréal	Quebec
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	The Johns Hopkins University	Baltimore	Maryland
United States	Beth Israel Deaconess	Boston	Connecticut
United States	Massachusetts General Hospital	Boston	Connecticut
United States	The University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ralph H Johnson VA Medical Center	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	University of Texas Medical Branch	Galveston	Texas
United States	Prisma Health	Greenville	South Carolina
United States	Indiana University	Indianapolis	Indiana
United States	Mount Sinai Health System	New York	New York
United States	Northwell Health	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	The Washington University	Saint Louis	Missouri
United States	MedStar	Washington	District of Columbia
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biodesix, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Nodule Diagnosis	Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution	Up to 24 months