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

Sponsor

Exact Sciences Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05064553

Collaborator

(none)

3,000

Enrollment

Locations

50.2

Anticipated Duration (Months)

88.2

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Hepatocellular Cancer Hepatitis B Cirrhosis Liver Cancer	Device: Study CT/MRI Imaging Device: Standard of Care CT/MRI Imaging Diagnostic Test: Oncoguard™ Liver Test

Detailed Description

Subjects age 18 years and older who are at an increased risk for HCC and for whom HCC surveillance is appropriate, including subjects with cirrhosis or non-cirrhotic subjects with Hepatitis B. Approximately 3,000 subjects are expected to be enrolled, comprised of approximately 2,222 ultrasound surveillance subjects and 778 subjects under surveillance with CT/MRI.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 26, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Ultrasound Surveillance Group Subjects will undergo standard of care ultrasound surveillance imaging. Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up with CT or MRI as well as other procedures as needed. Subjects with negative ultrasound will be sent for a study CT/MRI.	Device: Study CT/MRI Imaging Subjects with negative ultrasound will be sent for a study CT/MRI. Device: 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.
CT/MRI Surveillance Group Subjects will undergo standard of care CT/MRI surveillance imaging.	Diagnostic Test: Oncoguard™ Liver Test Subjects will have a blood sample collected for the Oncoguard™ Liver Test.

Arm

Intervention/Treatment

Ultrasound Surveillance Group

Subjects will undergo standard of care ultrasound surveillance imaging. Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up with CT or MRI as well as other procedures as needed. Subjects with negative ultrasound will be sent for a study CT/MRI.

Device: Study CT/MRI Imaging

Subjects with negative ultrasound will be sent for a study CT/MRI.

Device: 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.

CT/MRI Surveillance Group

Subjects will undergo standard of care CT/MRI surveillance imaging.

Diagnostic Test: Oncoguard™ Liver Test

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

Outcome Measures

Primary Outcome Measures

Sensitivity of Oncoguard™ Liver in a HCC surveillance population [A maximum of 30 days from study or standard-of-care CT or MRI exam.]
Specificity of Oncoguard™ Liver in a HCC surveillance population [A maximum of 30 days from study or standard-of-care CT or MRI exam.]

Secondary Outcome Measures

Sensitivity of Oncoguard™ Liver among confirmed HCC subjects [A maximum of 30 days from study or standard-of-care CT or MRI exam.]
Specificity of Oncoguard™ Liver among confirmed non-HCC subjects [A maximum of 30 days from study or standard-of-care CT or MRI exam.]
Early-stage sensitivity of Oncoguard™ Liver in a HCC surveillance population [A maximum of 30 days from study or standard-of-care CT or MRI exam.]

Other Outcome Measures

Overall and early-stage sensitivity as well as specificity of ultrasound [Treatment and outcomes data will be collected for up to 3 years post-enrollment.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be 18 years of age or older.
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.
Present for surveillance imaging due to increased risk for HCC, including either:
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

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

Exclusion Criteria:

Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.
Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.
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.
Females known to be pregnant at the time of enrollment.
Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to
Congestive heart failure with ejection fraction <50%
Chronic lung disease requiring supplemental oxygen.
History of recent stroke.
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.
Not able to have IV contrast for CT or MRI due to
Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication.
Estimated glomerular filtration rate <35 mL/min and not on hemodialysis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Health Research	Chandler	Arizona	United States	85225
2	Franco Felizarta, MD	Bakersfield	California	United States	93301
3	Gastroenterology & Liver Institute	Escondido	California	United States	92025
4	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
5	Providence Facey Medical Foundation	Mission Hills	California	United States	91345
6	United Medical Doctors	Murrieta	California	United States	92563
7	VA Palo Alto Healthcare System	Palo Alto	California	United States	94303
8	California Liver Research Institute	Pasadena	California	United States	91107
9	Cadena Care Institute	Poway	California	United States	92064
10	Inland Empire Clinical Trials	Rialto	California	United States	92377
11	Research & Education, Inc	San Diego	California	United States	92105
12	University of Florida Hepatology Research at CTRB	Gainesville	Florida	United States	32610
13	San Marcus Research Clinic	Miami Lakes	Florida	United States	33014
14	Indiana University	Indianapolis	Indiana	United States	46202
15	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana	United States	46237
16	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
17	Delta Research Partners	Monroe	Louisiana	United States	71201
18	Louisiana Research Center, LLC	Shreveport	Louisiana	United States	71105
19	University of Michigan	Ann Arbor	Michigan	United States	48109
20	Henry Ford Health System	Detroit	Michigan	United States	48202
21	Southern Therapy and Advanced Research LLC (STAR)	Jackson	Mississippi	United States	39216
22	St. Louis University	Saint Louis	Missouri	United States	63104
23	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
24	Manhattan Clinical Research, LLC	New York	New York	United States	10279
25	Digestive Health Partners	Asheville	North Carolina	United States	28801
26	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
27	Xiaoli Ma Md	Philadelphia	Pennsylvania	United States	19107
28	Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
29	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
30	Gastro One	Germantown	Tennessee	United States	38138
31	Texas Gastro Clinic	El Paso	Texas	United States	79936
32	UVA Gastroenterology	Charlottesville	Virginia	United States	22903
33	Digestive & Liver Disease Specialists	Norfolk	Virginia	United States	23502
34	Velocity Clinical Research	Spokane	Washington	United States	99202