Early Detection of Lung Cancer based on small RNA signatures

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.

Who Can Participate?

Eligibility

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 julie.poe@duke.edu.

Age Range

50-80

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Tina
Tailor

Protocol Number

PRO00112965

NCT ID

NCT05987189

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov