Clinical trial NCT04171492: Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nodule Solitary Pulmonary
Non-small Cell Carcinoma
Lead sponsor: Biodesix, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with newly identified, solid lung nodule determined to be low-moderate risk of cancer.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lung Nodule Diagnosis
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Connecticut
city: Boston
country: United States
facility: Beth Israel Deaconess
state: Connecticut
city: Washington
country: United States
facility: MedStar
state: District of Columbia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: The Washington University
state: Missouri
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Coulmbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Charleston
country: United States
facility: Ralph H Johnson VA Medical Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Biodesix, Inc.
name: Steven Springmeyer
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Gerard Silvestri, MD
role: PRINCIPAL_INVESTIGATOR
References: