Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT02512757
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 \< 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02512757
Study Brief:
Protocol Section:
NCT02512757