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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05064553
Recruitment Status : Active, not recruiting
First Posted : October 1, 2021
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Study Description
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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
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
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Study Type : Observational
Estimated 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 : July 26, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Sensitivity of Oncoguard™ Liver in a HCC surveillance population [ Time Frame: A maximum of 30 days from study or standard-of-care CT or MRI exam. ]
  2. Specificity of Oncoguard™ Liver in a HCC surveillance population [ Time Frame: A maximum of 30 days from study or standard-of-care CT or MRI exam. ]

Secondary Outcome Measures :
  1. Sensitivity of Oncoguard™ Liver among confirmed HCC subjects [ Time Frame: A maximum of 30 days from study or standard-of-care CT or MRI exam. ]
  2. Specificity of Oncoguard™ Liver among confirmed non-HCC subjects [ Time Frame: A maximum of 30 days from study or standard-of-care CT or MRI exam. ]
  3. Early-stage sensitivity of Oncoguard™ Liver in a HCC surveillance population [ Time Frame: A maximum of 30 days from study or standard-of-care CT or MRI exam. ]

Other Outcome Measures:
  1. Overall and early-stage sensitivity as well as specificity of ultrasound [ Time Frame: Treatment and outcomes data will be collected for up to 3 years post-enrollment. ]

Biospecimen Retention:   Samples With DNA
Samples derived from the blood collection may not be used in their entirety. Residual samples may be archived for up to 7 years for further analysis and future research. Blood samples will be labeled with unique codes containing letters and numbers.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05064553


Locations
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Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Principal Investigator: Binu John Miami VA Healthcare System
More Information
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT05064553    
Other Study ID Numbers: 2021-01
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and the clinical study report (when applicable) will also be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available from 2 years and ending 4 years after publication.
Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/IEC approvals or waivers as applicable to conduct research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Exact Sciences Corporation:
Blood Sample Collection
CT/MRI
Ultrasound
Combined Hepatocellular and Cholangiocarcinoma
HCC Surveillance
Additional relevant MeSH terms:
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Hepatitis B
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hepatitis
Liver Diseases
Digestive System Diseases
 Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human