Early Detection of Lung Cancer based on small RNA signatures - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental technology called the HBDx Small RNA Diagnostic Test for Lung Cancer can help diagnose people with lung cancer early.

What is the Condition Being Studied?

Early Detection of Lung Cancer

Who Can Participate in the Study?

Adults ages 50-80 who:

  • Received a Lung-RADS category 3 or 4 on a lung cancer screening exam and have been referred for more testing
  • Have completed a lung cancer screening exam within the past 120 days
  • Have not had any procedures that required cuts into the skin or a tool inserted into the body (e.g., biopsy, bronchoscopy, surgery) for lung cancer testing

For more information about who can join this study, please contact the study team at alex.sents@duke.edu.

Age Group

What is Involved?

If you choose to join this study, you will:

  • Come to our clinic for 1 visit
  • Have blood draws (from a vein and finger prick test)
  • Fill out questionnaires
  • Give us permission to collect and record the results of any medical tests or imaging you have after your study visit (for example: biopsy results, CT scans, X-rays, etc.)

We will call you about a year after your visit to see if you had any medical tests or procedures done at any other healthcare facilities besides Duke. We will compensate you for your time to come in for the study visit.

Study Details

Full Title
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?
Principal Investigator
Cardiothoracic Imaging Specialist
Protocol Number
IRB: PRO00112965
NCT: NCT05987189
Phase N/A
Enrollment Status
Open for Enrollment