Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-25 @ 1:49 PM
Study NCT ID:
NCT04171492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2019-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules
Sponsor:
Biodesix, Inc.
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALTITUDE
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: