ALTUS (Hepatocellular Carcinoma [Liver Cancer] Detection)

Purpose of this Study

We are doing this study to find out if an experimental test for the detection of hepatocellular carcinoma (liver cancer) called Oncoguard® is a reliable and accurate means to detect the disease in its earliest stages.

Who Can Participate?

Eligibility

Adults ages 55+ who:
  • Are diagnosed with liver cirrhosis
  • Are scheduled to have routine liver ultrasounds for cancer surveillance
  • Do not have any history of esophageal bleeding or mental confusion related to liver disease
  • Have not had any form of active cancer in the past 5 years (some skin cancers are OK)
For more information, contact the study team at laura.hayes@duke.edu.

Age Range

55-110

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:
  • Have blood draws
  • Have a CT scan within 30 days of your regularly scheduled liver ultrasound
  • Give us permission to collect information about your liver health from your medical records
Participation in this study will involve 3 visits to our clinic over the course of about 8 months.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

ALTUS: Performance of a Multi-Target Hepatocellular Carcinoma (HCC) Test in Subjects with Increased Risk

Principal Investigator

Cynthia
Moylan

Protocol Number

PRO00115210

NCT ID

NCT05064553

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov