LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

NCT05171491 | Active Not Recruiting

• 1 other identifier: LAI-001
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 12

Brief Summary

Correlate performance of LungLB Test with outcome of a scheduled biopsy.

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Keywords

Lung Cancer; Circulating Genetically Abnormal Cells (CGAC); 4-color FISH; Increased/Decreased Risk; Early Lung Cancer Detection; Indeterminate Nodule

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.

  up to 60 days

Secondary Outcomes (1)

• Evaluate Clinical Variables With and Without LungLB Test Results

  up to 60 days

Study Arms (1)

Indeterminate Lung Nodule

Subjects that present with indeterminate lung nodules at time of biopsy. No intervention outside of standard of care.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with suspicious indeterminate pulmonary nodules identified incidentally or through a lung cancer screening program. up to 15 institutions geographically distributed across the US.

You may qualify if:

• At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.
• Planned biopsy nodule of interest:
• is solid ≤3 cm; or
• is nonsolid, ground glass opacity, of any size; or
• is part solid, where the solid component is no larger than 3cm (maximum diameter).

You may not qualify if:

• Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
• Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.

Sponsors & Collaborators

• LungLife AI: lead

Study Sites (12)

Clinical Site 04

Los Angeles, California, 90095, United States

Location

Clinical Site 05

Bay Pines, Florida, 33744, United States

Location

Clinical Site 03

Miami, Florida, 33136, United States

Location

Clinical Site 07

Hines, Illinois, 60141, United States

Location

Clinical Site 27

Kansas City, Kansas, 64111, United States

Location

Clinical Site 12

Wichita, Kansas, 67218, United States

Location

Clinical Site 08

Kansas City, Missouri, 64128, United States

Location

Clinical Site 18

Reno, Nevada, 89502, United States

Location

Clinical Site 01

New York, New York, 10029, United States

Location

Clinical Site 25

Columbia, South Carolina, 29203, United States

Location

Clinical Site 02

Houston, Texas, 77030, United States

Location

Clinical Site 32

Milwaukee, Wisconsin, 53295, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

White blood cells and plasma.

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Michael Donovan, MD

  LungLife AI

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 29, 2021
• Study Start: January 26, 2022
• Primary Completion: December 30, 2023
• Study Completion: September 2, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)