Spots Global Cancer Trial Database for A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology

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Trial Identification

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

Official Title: The AminoIndex™ Study - A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology

Study ID: NCT02512757

Conditions

Lung Cancer

Interventions

Study Description

Brief Summary: 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.

Detailed 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).