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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05064553
• Other study ID #: 2021-01
• Status: Recruiting
• Start date: July 26, 2021
• Est. completion date: April 2026

Study information

• Verified date: December 2023
• Source: Exact Sciences Corporation
• Contact: Brian Blend
• Phone: 412-400-6662
• Email: bblend[@]exactsciences.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.

Description:

The study will include participants aged 18 years and older who are at increased risk for HCC, including individuals with liver cirrhosis or non-cirrhotic individuals with chronic hepatitis B infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: April 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be 18 years of age or older.

2. 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.

3. Present for surveillance imaging due to increased risk for HCC, including either:

1. Diagnosis of cirrhosis based on at least one of the following:

• Histology from a liver biopsy.
• Ultrasound, CT, or MRI showing a cirrhotic liver combined with portal hypertension (as evidenced by the presence of intra-abdominal varices, or recanalized umbilical vein, or ascites or splenomegaly or thrombocytopenia [defined as Platelet count < 150,000]). The imaging results must have been obtained within 5 years of study enrollment.
• Liver stiffness =4.71 kilopascal (kPa) by Magnetic Resonance (MR) elastography or =12.1 kPa by vibration controlled transient elastography.
• Presence of varices on endoscopy or imaging and presence of a chronic liver disease. OR

2. Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for >6 months)

Exclusion Criteria:

1. Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.

2. Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.

3. Known Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.

4. 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.

5. Females known to be pregnant at the time of enrollment.

6. Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to

1. Congestive heart failure with ejection fraction <50%

2. Chronic lung disease requiring supplemental oxygen.

3. History of recent stroke.

7. Sustained virologic response (SVR) for Hepatitis C Virus (HCV) (undetectable HCV RNA 12 to 24 weeks after completion of antiviral therapy) for >10 years prior to enrollment.

8. Not able to have IV contrast for CT or MRI due to

1. Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication.

2. Estimated glomerular filtration rate <35 mL/min and not on hemodialysis.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatitis B
• Hepatocellular Cancer
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• Study CT/MRI Imaging
Subjects with negative ultrasound will be sent for a study CT/MRI.
• Standard of Care CT/MRI Imaging
Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.

Diagnostic Test:
• Oncoguard™ Liver Test
Subjects will have a blood sample collected for the Oncoguard™ Liver Test.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Digestive Health Partners	Asheville	North Carolina
United States	Franco Felizarta, MD	Bakersfield	California
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Great Lakes Medical Research - Susquehanna Research Group	Camp Hill	Pennsylvania
United States	Arizona Health Research	Chandler	Arizona
United States	Ralph H Johnson VAMC	Charleston	South Carolina
United States	UVA Gastroenterology	Charlottesville	Virginia
United States	VA North East Ohio Health Care System	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Health Systems	Durham	North Carolina
United States	Texas Gastro Clinic	El Paso	Texas
United States	Gastroenterology & Liver Institute	Escondido	California
United States	University of Florida Hepatology Research at CTRB	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	Indiana University	Indianapolis	Indiana
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Southern Therapy and Advanced Research LLC (STAR)	Jackson	Mississippi
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	UW Digestive Health Center	Madison	Wisconsin
United States	Gastroenterology Associates, PC	Manassas	Virginia
United States	Miami VA Healthcare System	Miami	Florida
United States	University of Miami	Miami	Florida
United States	San Marcus Research Clinic	Miami Lakes	Florida
United States	Providence Facey Medical Foundation	Mission Hills	California
United States	Delta Research Partners	Monroe	Louisiana
United States	United Medical Doctors	Murrieta	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Manhattan Clinical Research, LLC	New York	New York
United States	Digestive & Liver Disease Specialists	Norfolk	Virginia
United States	Stanford University Medical Center	Palo Alto	California
United States	VA Palo Alto Healthcare System	Palo Alto	California
United States	California Liver Research Institute	Pasadena	California
United States	Corporal Michael J. Crescenz VA Medical Center	Philadelphia	Pennsylvania
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Xiaoli MA MD	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Cadena Care Institute	Poway	California
United States	Inland Empire Clinical Trials	Rialto	California
United States	Richmond VA Medical Center	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	St. Louis University	Saint Louis	Missouri
United States	Research & Education, Inc	San Diego	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Velocity Clinical Research	Spokane	Washington
United States	Washington DC VA Medical Center	Washington	District of Columbia
United States	Wilkes-Barre VA Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin		A maximum of 30 days from study or standard-of-care CT or MRI exam.
Primary	To demonstrate that Oncoguard™ Liver HCC specificity exceeds 82%		A maximum of 30 days from study or standard-of-care CT or MRI exam.
Secondary	To determine a point estimate and 95% confidence interval for Oncoguard™ Liver overall HCC sensitivity		A maximum of 30 days from study or standard-of-care CT or MRI exam.