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

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

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

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All Groups: Able to read, understand and sign informed consent to participate in study. Willing and able to provide written informed consent. Willing and able to meet all study requirements and undergo venipuncture to provide a fasting blood sample. Group 1: Men or women age 18 years or older; Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung, nodule or mass. Diagnosis of lung cancer based upon histopathology performed on lung nodule, lesion or mass tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained. Group 2: Men or women age 18 years or older; Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung nodule, lesion or mass; Definitive diagnosis of benign (non-cancerous) lung nodule based upon one of the following: Histopathology performed on lung nodule tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained; No nodule growth for > 2 years by repeat CT imaging, the most recent being performed within the 60 days prior to signing informed consent. Group 3: Men or women age 55-79 years inclusive; Current smoker or quit < 15 years ago with a > 30 pack-year smoking history (equivalent of 1 pack per day for 30 or more years)*. Have undergone low-dose computed tomography (LDCT) or standard computed tomography (CT) or X-ray testing to screen for lung cancer with no nodules suspicious for lung cancer within 1 year prior to signing informed consent. ' * ' One pack year is calculated as follows: 20 cigarettes = 1 pack. One pack year is the equivalent of smoking: 20 cigarettes (one pack) per day for one year; or 40 cigarettes (two packs) per day for 6 months; or 60 cigarettes (three packs) per day for 3 months Exclusion Criteria Inability to fast for 8 hours prior to the blood sample collection. Known to be positive for HIV and/or, HBV and/or HCV. Pregnancy. Breastfeeding. Currently undergoing dialysis. Congenital metabolic disease. Currently receiving investigational treatments of any type. History of receiving any drug therapy or surgery for the treatment of lung cancer. Diagnosis of cancer within past 5 years and/or currently undergoing treatment for any cancer. Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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 will contribute a fasting blood sample. | |
| Group 2<br>Patients whose most recent screening imaging is within 60 days who have 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 will contribute a fasting blood sample. | |
| Group 3<br>Patients who have undergone low-dose computed tomography (LDCT) or standard computed tomography (CT) or X-ray testing to screen for lung cancer with no nodules suspicious for lung cancer within 1 year prior to signing informed consent will contribute a fasting blood sample. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic performance of AminoIndex™ to discriminate lung cancer patients from high-risk subjects. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Lung, Pulmonary Neoplasms, Pulmonary Cancer