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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
. 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.
. Known 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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.

Trial details

NCT IDNCT05064553

SponsorExact Sciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-12

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
. 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.
. Known 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.

What they're measuring

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.

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.