A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
Purpose
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.
Condition
- Lung Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 79 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Group 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 will contribute a fasting blood sample. | |
| Group 2 | 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 | 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. |
More Details
- Status
- Completed
- Sponsor
- Innovis LLC
Study Contact
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).