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

Study Overview
=================
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.

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

Conditions
-----------------
Nodule Solitary Pulmonary, Non-small Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements Subject is > 40 years of age at the time of the discovery of the lung nodule of concern 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 The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less Exclusion Criteria: 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 Nodule of concern is part-solid or Ground Glass Opacity (GGO) Prior diagnosis of lung cancer Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern Any illness or factor that will inhibit compliance with study participation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Label<br>Nodify XL2 results will be reported to the investigator and available to the subject. | |
| Blinded<br>Nodify XL2 results will not be available to the investigative site or subject. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |