A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
Completed
Conditions studied: Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT02512757
- Run by
- Innovis LLC
- People needed
- 150
- Starts
- 2015-08-13
- Expected to finish
- 2017-07-17
- Last updated by the study team
- 2018-02-28
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Florida Lung Asthma and Sleep Specialists P.A. — Celebration, Florida, United States
- Pulmonary and Critical Care Associates of Baltimore — Baltimore, Maryland, United States
- Vanderbilt-Ingram Cancer Center (VICC) — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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