ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increa… (NCT05064553) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
United States2,990 participantsStarted 2021-07-26
Plain-language summary
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Be 18 years of age or older.
âś“. Understand the study procedures, be able to provide written informed consent to participate in the study, and have authorization for release of data, including personal health data and images, to the study Investigator, Sponsor, and regulatory authorities.
âś“. Present for surveillance imaging due to increased risk for HCC, including either:
âś“. Diagnosis of cirrhosis based on at least one of the following:
âś“. Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for \>6 months)
Exclusion criteria
âś•. Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.
âś•. Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
âś•. Known Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.
âś•. Solid liver nodule \>1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (\>100 ng/mL) in 12 months preceding the qualifying surveillance imaging visit without subsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting and Data System) by diagnostic CT/MRI.
âś•. Females known to be pregnant at the time of enrollment.
âś•. Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to
What they're measuring
1
To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin
Timeframe: A maximum of 30 days from study or standard-of-care CT or MRI exam.
2
To demonstrate that Oncoguard™ Liver HCC specificity exceeds 82%
Timeframe: A maximum of 30 days from study or standard-of-care CT or MRI exam.