Nodify XL2 Classifier Clinical Utility Study in Low to Mo... | NCT04171492

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2020Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Nov 19, 2019

First Submission Date that Met QC Criteria

Nov 19, 2019

First Posted Date

Nov 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 19, 2025Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Label	Type	Description	Intervention Names
Open Label		Nodify XL2 results will be reported to the investigator and available to the subject.
Blinded		Nodify XL2 results will not be available to the investigative site or subject.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with newly identified, solid lung nodule determined to be low-moderate risk of cancer.

Sampling Method

Probability Sample

Name	Affiliation	Role
Steven Springmeyer	Biodesix, Inc.	Principal Investigator
Gerard Silvestri, MD	Medical University of South Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado		Aurora	Colorado	80045	United States
Massachusetts General Hospital

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases