Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung

Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung "Early Detection of Lung Cancer Based on Small RNA Signatures - Boston II"

2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.

The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer.

Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years.

Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.

Inclusion Criteria:

• Adult male and female patients, aged 50 to 80 years
• Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer
• Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
• Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
• Able and willing to provide informed consent

Exclusion Criteria:

• Prior history of diagnosed lung cancer
• History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
• Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
• Immunosuppressive medication
• Deemed not able to participate in the study by the investigator