Simple blood test aims to catch liver cancer before It's too late
NCT ID NCT05199259
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This study is testing a new blood test designed to detect liver cancer (hepatocellular carcinoma) early in people who are at high risk because they have cirrhosis. The test looks for specific DNA markers and proteins in the blood that may signal the presence of cancer. Researchers will collect blood samples from participants with and without liver cancer to see how accurate the test is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Multi-analyte Blood Test
- What this could lead to
- If successful, this blood test could offer a simple, non-invasive way to catch liver cancer early in people with cirrhosis, potentially improving survival.
- What could go wrong
- This is a development and validation study, not a treatment trial. The test may not prove accurate enough for widespread use, and false positives or negatives are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The subjects will fall into two main groups, subjects diagnosed with HCC (HCC positive Group) or subjects without HCC (HCC negative Group). The HCC negative Group will be further divided into two sub-groups based on whether the absence of HCC has been determined using CT or MRI procedures (Sub-group 1) or ultrasound (Sub-group 2). Only the subjects in sub-group 2 will receive a confirmatory ultrasound approximately 6 months (between 5 to 7 months) after enrollment to confirm the absence of HCC ("6-month visit). This additional imaging study is necessary due to the low sensitivity of abdominal ultrasound to detect HCC lesions. The blood specimens will be shipped to a clinical diagnostic laborator
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older. * Males and Females. * Having cirrhosis or meeting the AASLD guidelines for HCC * surveillance. * Clinically diagnosed with HCC or negative for HCC following disease * surveillance. * HCC positive Group: Subject has a recent (within 6 months of enrollment) clinically diagnosed, untreated hepatocellular carcinoma as defined by at least one ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC. * HCC negative Group: Non-cancer, at-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC, where the definitive lack of HCC within 3 months prior to enrollment has been verified by negative imaging, for HCC. No more than 200 subjects without cirrhosis can be enrolled in this group. * Sub-Group 1 (approximately 450 subjects) - negative by CT or MRI (No lesion, LR-1 or LR-2) * Sub-Group 2 (approximately 450 subjects) - negative by ultrasound Exclusion Criteria: * Subjects that are unwilling or unable to sign the Informed Consent Form will be excluded. * Known cancer diagnosis of a cancer other than HCC within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers). * Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. * Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC. * Prior treatment with a DNA methyltransferase inhibitor such as with Vidaza (azacitidine) or Dacogen (decitabine) * Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC). * IV contrast (e.g., CT and MRI) within 1 day \[or 24 hours\] of blood collection. * Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection. * Less than 7 days between biopsy (other than FNA) of target pathology and blood collection. * Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. * For HCC negative subjects, patients with a prior diagnosis of HCC are also excluded. * Subjects that are pregnant will be exclude
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gastroenterology and Liver Institute
RECRUITINGEscondido, California, 02025, United States
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Guardian Angel Research Center
RECRUITINGTampa, Florida, 33614, United States
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Impact Research Institute
RECRUITINGWaco, Texas, 76710, United States
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Providence Facey Medical Foundation
RECRUITINGMission Hills, California, 91345, United States
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South Texas Research Institute
RECRUITINGEdinburg, Texas, 78539, United States
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Texas Gastro Research
RECRUITINGEl Paso, Texas, 79936, United States
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UF Hepatology Research at CTRB
RECRUITINGGainesville, Florida, 32610, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an antioxidant boost the Body's fight against a deadly infection in cirrhosis?
- A single blood draw to detect five cancers before symptoms appear?
- Can cirrhosis make colon polyp removal riskier? a study digs into bleeding rates.
- Can a smaller stent tame brain fog after liver shunt surgery?