Clinical trial NCT05064553: ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
Official title: ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Hepatocellular Cancer
Hepatitis B
Cirrhosis
Liver Cancer
Keywords: Blood Sample Collection
CT/MRI
Ultrasound
Combined Hepatocellular and Cholangiocarcinoma
HCC Surveillance
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years of age and older who are at an increased risk for HCC and for whom HCC surveillance is appropriate, including subjects with cirrhosis and non-cirrhotic subjects with Hepatitis B.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
measure: 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.
Secondary outcomes:
measure: To determine a point estimate and 95% confidence interval for Oncoguard™ Liver overall HCC sensitivity
timeFrame: A maximum of 30 days from study or standard-of-care CT or MRI exam.
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Health Research
state: Arizona
city: Sun City
country: United States
facility: Arizona Digestive Health - Sun City
state: Arizona
city: Bakersfield
country: United States
facility: Franco Felizarta, MD
state: California
city: Escondido
country: United States
facility: Gastroenterology & Liver Institute
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Mission Hills
country: United States
facility: Providence Facey Medical Foundation
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Healthcare System
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Poway
country: United States
facility: Cadena Care Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials
state: California
city: San Diego
country: United States
facility: Research & Education, Inc
state: California
city: San Jose
country: United States
facility: San Jose Gastroenterology
state: California
city: Littleton
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Washington, DC
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Hepatology Research at CTRB
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland Groover Clinical Research
state: Florida
city: Lakewood
country: United States
facility: Florida Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Downers Grove
country: United States
facility: Digestive Health Services
state: Illinois
city: Glenview
country: United States
facility: Illinois Gastroenterology Group
state: Illinois
city: Lake Barrington
country: United States
facility: Gastroenterology and Internal Medicine Specialists
state: Illinois
city: Oak Lawn
country: United States
facility: Avicenna Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: NAVREF - Indiana Institute for Medical Research (IIMC)
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Nottingham
country: United States
facility: Patient First Clinical Trials
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research LLC (STAR)
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Brooklyn
country: United States
facility: Brooklyn VA Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Manhattan Clinical Research, LLC
state: New York
city: Asheville
country: United States
facility: Digestive Health Partners
state: North Carolina
city: Durham
country: United States
facility: Duke University Health Systems
state: North Carolina
city: Cleveland
country: United States
facility: VA North East Ohio Health Care System
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Camp Hill
country: United States
facility: Great Lakes Medical Research - Susquehanna Research Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Xiaoli MA MD
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Wilkes-Barre VA Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology West River
state: Rhode Island
city: Charleston
country: United States
facility: Ralph H Johnson VAMC
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Texas Gastro Clinic
state: Texas
city: Lubbock
country: United States
facility: Lubbock Digestive Disease Associates
state: Texas
city: San Marcos
country: United States
facility: Texas Digestive Disease Consultants - San Marcos
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: UVA Gastroenterology
state: Virginia
city: Manassas
country: United States
facility: Gastroenterology Associates, PC
state: Virginia
city: Norfolk
country: United States
facility: Digestive & Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Richmond VA Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology - Bellevue
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Velocity Clinical Research
state: Washington
city: Tacoma
country: United States
facility: Washington Gastroenterology - Tacoma
state: Washington
city: Madison
country: United States
facility: UW Digestive Health Center
state: Wisconsin
Study officials:
affiliation: Miami VA Healthcare System
name: Binu John
role: PRINCIPAL_INVESTIGATOR
References: