Clinical Trials

Clinical Trial Number: Boston II

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

Study ID: Boston II
Phase N/A
Physician Investigator(s)
Study Locations

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.

Eligibility Criteria

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