A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
- Conditions
- Lung Cancer
- Registration Number
- NCT02512757
- Lead Sponsor
- Innovis LLC
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The diagnostic performance of AminoIndex™ to discriminate lung cancer patients from high-risk subjects. 6 months 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.
- Secondary Outcome Measures
Name Time Method The capability of AminoIndex™ to distinguish malignant lung cancer from benign lung nodules. 6 months Gathering residual patient samples that will be used for discovery research. 6 months
Trial Locations
- Locations (3)
Florida Lung Asthma and Sleep Specialists P.A.
🇺🇸Celebration, Florida, United States
Pulmonary and Critical Care Associates of Baltimore
🇺🇸Baltimore, Maryland, United States
Vanderbilt-Ingram Cancer Center (VICC)
🇺🇸Nashville, Tennessee, United States