A Case-Control Study to Verify Diagnostic Performance of AminoIndex™

Status Completed

Clinical Trial Summary

Clinical Trial Description

This is a prospective, multi-center study to evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk for developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy and histopathology.

The study will enroll patients into one of three arms:

1. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and diagnosed with primary lung cancer who have not yet initiated treatment of any kind for their lung cancer;

2. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and determined to not be cancerous OR that have demonstrated no nodule growth for > 2 years by repeat CT imaging; and

3. patients at high-risk for lung cancer (per NLST guidelines) with no evidence or history of lung cancer (negative LDCT/CT/X-ray). ;

Study Design

Related Conditions & MeSH terms

Lung Cancer

Clinical Trial Details

NCT number	NCT02512757
Study type	Observational
Source	Innovis LLC
Contact
Status	Completed
Phase	N/A
Start date	August 13, 2015
Completion date	July 17, 2017

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A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms