A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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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;
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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
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patients at high-risk for lung cancer (per NLST guidelines) with no evidence or history of lung cancer (negative LDCT/CT/X-ray).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria
All Groups:
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Able to read, understand and sign informed consent to participate in study.
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Willing and able to provide written informed consent.
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Willing and able to meet all study requirements and undergo venipuncture to provide a fasting blood sample.
Group 1:
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Men or women age 18 years or older;
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Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung, nodule or mass.
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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:
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Men or women age 18 years or older;
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Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung nodule, lesion or mass;
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Definitive diagnosis of benign (non-cancerous) lung nodule based upon one of the following:
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Histopathology performed on lung nodule tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained;
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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:
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Men or women age 55-79 years inclusive;
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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)*.
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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:
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20 cigarettes (one pack) per day for one year; or
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40 cigarettes (two packs) per day for 6 months; or
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60 cigarettes (three packs) per day for 3 months
Exclusion Criteria
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Inability to fast for 8 hours prior to the blood sample collection.
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Known to be positive for HIV and/or, HBV and/or HCV.
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Pregnancy.
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Breastfeeding.
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Currently undergoing dialysis.
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Congenital metabolic disease.
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Currently receiving investigational treatments of any type.
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History of receiving any drug therapy or surgery for the treatment of lung cancer.
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Diagnosis of cancer within past 5 years and/or currently undergoing treatment for any cancer.
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Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Lung Asthma and Sleep Specialists P.A. | Celebration | Florida | United States | 34747 |
| 2 | Pulmonary and Critical Care Associates of Baltimore | Baltimore | Maryland | United States | 21237 |
| 3 | Vanderbilt-Ingram Cancer Center (VICC) | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Innovis LLC
- Ajinomoto Co., Inc.
Investigators
- Study Director: Gregg S. Britt, Innovis LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Ajinomoto 2015-01