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New treatment option for Carcinoma, Hepatocellular
Official title National Liver Cancer Screening Trial
ClinicalTrials.gov ID: NCT06084234
What this study is testing
- What it's testing
- The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patient must meet all of the following
- Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of...
- Patient is eligible for HCC surveillance according to treating physician or by the site investigator
- Able to provide informed consent
- Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator
You likely can't join if
- Patient will be excluded for any of the following exclusion criteria:
- Child Pugh C cirrhosis
- History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
- History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI...
- AFP \>20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level...
- Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
See the full eligibility criteria
- Patient must meet all of the following
- Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment
- Patient is eligible for HCC surveillance according to treating physician or by the site investigator
- Able to provide informed consent
- Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator
- Patient will be excluded for any of the following exclusion criteria:
- Child Pugh C cirrhosis
- History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
- History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature)
- AFP \>20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions
- Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
- History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent
- Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent
- Patient's provider is planning to use MRI- or CT- based surveillance moving forward
- History of a transjugular intrahepatic portosystemic shunt (TIPS)
- History of Fontan associated liver disease or cardiac cirrhosis
- History of solid organ transplantation
- Actively listed for liver transplantation
- Diagnosis of alcohol-associated hepatitis within 3 months prior to consent
- Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)
- In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent
- Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)
- In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent
- Known pregnancy at consent
- Active warfarin use
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Redwood City, California, United States
- Roseville, California, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Manhasset, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Redwood City, California, United States; Roseville, California, United States; San Francisco, California, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.