Lung Cancer
Conditions
Keywords
Neoplasms, Lung, Pulmonary Neoplasms, Pulmonary Cancer
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).
Interventions
None listed
Sponsors
Ajinomoto Co., Inc.
Innovis LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
United States
Outcome results
None listed