a case-control study to verify diagnostic performance of aminoindex™ technology

Conditions: Lung Cancer

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.

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).

Eligibility criteria:
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 \ 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.

Keywords: neoplasms, lung pulmonary neoplasms pulmonary cancer