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:<ul>
<li>Received a Lung-RADS category 3 or 4 on a lung cancer screening exam and have been referred for more testing</li>
<li>Have completed a lung cancer screening exam within the past 120 days</li>
<li>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</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: alex.sents@duke.edu">alex.sents@duke.edu.</a>
<li>Received a Lung-RADS category 3 or 4 on a lung cancer screening exam and have been referred for more testing</li>
<li>Have completed a lung cancer screening exam within the past 120 days</li>
<li>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</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: alex.sents@duke.edu">alex.sents@duke.edu.</a>
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?
If you choose to join this study, you will:<ul>
<li>Come to our clinic for 1 visit</li>
<li>Have blood draws (from a vein and finger prick test)</li>
<li>Fill out questionnaires</li>
<li>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.)</li></ul>
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.
<li>Come to our clinic for 1 visit</li>
<li>Have blood draws (from a vein and finger prick test)</li>
<li>Fill out questionnaires</li>
<li>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.)</li></ul>
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?
?Early Detection of Lung Cancer based on small RNA
signatures - Boston II?
Principal Investigator
Edward
Patz
Protocol Number
PRO00112965
NCT ID
NCT05987189
Phase
N/A
Enrollment Status
Open to Enrollment