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Liver CancerSTOP-HCCNCT05342350

International Study of High-Risk Patients for Hepatocellular Carcinoma Using Liquid Biopsy

An observational study of Liver Cancer and Liver Cirrhosis, run by Johns Hopkins University at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study has two purposes. One is to conduct a phase IV biomarker validation study in which the investigators will prospectively survey a cohort of patients at risk for liver cancer using semi-annual abdominal ultrasound and GALAD Score for 5 years. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GALAD Score
How many people
360 participants
Where
10 sitesin 2 countries
Study dates
15 Apr 2022to 7 Jun 2025
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Persons with compensated cirrhosis (e.g. MELD 15 or lower)

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study and up to 5 years post-study follow up
  • Adults aged 18 or older
  • Both genders and all ethnicities
  • Willingness to give written, informed consent to be enrolled into the database
  • Collection of biosamples (serum, plasma, and urine) at each of the 6 months follow up during the study duration
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  • Individuals already confirmed to have cirrhosis with MELD ≤ 15 from any etiology (chronic HBV, chronic HCV, NASH cirrhosis, etc.)
  • For chronic HBV and/or /HCV carrier, with or without on treatment
  • Reside in Vietnam or Saudi Arabia at the time of study and provides contact information (email and/or cell phone number for texting)
  • No prior or current treatment of HCC
  • No cancer history within 5 years
  • No participation in a trial for HCC Treatment
  • No prior solid organ transplant
  • Albumin, Bilirubin, Creatinine and INR labs within past 30 days
  • Imaging showing no HCC within 180 days
  • Diagnosis of fibrosis and cirrhosis based on: histology, image showing cirrhotic liver with splenomegaly and platelets <120 mm3, or esophageal or gastric varices on endoscopy AND presence of chronic liver disease/Fibroscan/Fib-4/APRI/ARFI. For viral hepatitis, kPa>=9kPa, APRI >=1; for NAFLD/NASH (FIB-4 > 1.3 \& TE > 8kPa)
  • No significant hepatic decompensation
  • No hepatorenal syndrome
  • AFP labs within 180 days irrespective of AFP titer
  • Two phone numbers and personal identification numbers (CMND number)
  • No known AIDS related diseases
  • No significant co-morbid conditions with life expectancy <5 years
  • No other cancer(s)

Who cannot join

  • Decompensated cirrhosis (variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, and/or hepatorenal syndrome) or MELD>15
  • Individuals who already have HCC, with or without HCC treatment
  • On liver transplantation list or anticipated to be on the liver transplantation list during the study duration
  • Individuals who cannot, do not want to, or refused to sign the informed consent form (ICF)
  • Any serious or active medical or psychiatric illness, which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol
  • Documentation was not adequate
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  • Taking Vitamin K within 7 days prior to clinic follow or having disease affecting Vitamin K levels.
  • Known HIV positive
  • Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Saudi Arabia5 sites

  • King Faisal Specialist Hospital and Research Center in Jeddah

    Jeddah

  • National Guard Hospital in Jeddah

    Jeddah

  • King Faisal Specialist Hospital and Research Centre in Riyadh

    Riyadh

  • King Saud University Medical Center

    Riyadh

  • National Guard Hospital in Riyadh

    Riyadh

Other trials in Saudi Arabia

Vietnam5 sites

  • Medic Ca Mau

    Ca Mau

  • Dong Da Hospital

    Hà Nội

  • Institute of Gastroenterology and Hepatology

    Hà Nội

  • Medic Medical Center-Ho Chi Minh City

    Ho Chi Minh City

  • Binh An Hospital

    Rach Gia, Kien Giang

Other trials in Vietnam

About this study

Official title: Surveillance and Treatment Of Primary Hepatocellular Carcinoma: An International Cohort Study of High-Risk Patients for HCC Using Liquid Biopsy

This study has two purposes. One is to conduct a phase IV biomarker validation study in which the investigators will prospectively survey a cohort of patients at risk for liver cancer using semi-annual abdominal ultrasound and GALAD Score for 5 years. The GALAD score is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. One is to establish a bio-repository of longitudinally collected bio-specimens from patients with fibrosis/cirrhosis as a reference set for future research.

Read the detailed description

Vietnam and Saudi Arabia have some of the highest disease burdens of liver cancer globally. Early detection in asymptomatic patients who are at risk for liver is a strategy to improve survival outcomes in liver cancer management. GALAD score (gender, age, alpha-feto protein (AFP)-L%, AFP and DCP) is a serum biomarker-based panel that can improve HCC early detection in patients with liver fibrosis and cirrhosis. In case-control studies and studies with the design of prospective specimen collection, and retrospective blinded evaluation, GALAD has demonstrated promising clinical utility. However, in order to ascertain its potential role in the surveillance of liver cancer early detection, GALAD needs to be validated prospectively for clinical surveillance of liver cancer (i.e. phase IV biomarker validation study). Thus, the investigators propose to conduct a phase IV biomarker validation study to prospectively survey a cohort of patients at risk for HCC (i.e. patients with compensated cirrhosis and irrespective of cirrhosis etiologies), using semi-annual abdominal ultrasound and GALAD Score for 5 years. In doing so, the investigators aim to validate the potential role of GALAD Score for clinical surveillance and early detection of HCC in Vietnam and Saudi Arabia. Additionally, the investigators will collect and archive biospecimens to develop a bio-repository for liver disease. The biorepository will encourage the sharing of biospecimens and collaboration among physicians or physician-researchers between the US, Vietnam, and Saudi Arabia.

Being tested
GALAD Score
Keywords
Early detection of liver cancer, GALAD, Liver cancer, Viet Nam, Saudi Arabia, Liver cirrhosis
Medical subject headings
Liver Neoplasms, Liver Cirrhosis, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GALAD ScoreOther

    GALAD score, a blood-based biomarker panel (gender, age, AFP, AFP-L3%, DCP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GALAD performance for liver cancer early detection

    Performance of GALAD score determined in association with liver cancer detection by LiRADS criteria in a cohort with compensated cirrhosis undergoing prospective surveillance every 6 months for 5 years.

    Measured: 5 years

Secondary outcomes (1)

  1. Establishment of a bio-repository of longitudinally collected from patients with cirrhosis to be used for future studies

    Proportion of study participants agrees to consent for bio-specimen when invited

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start15 Apr 2022
  3. Primary completion7 Jun 2025
  4. Study completion7 Jun 2025

Why it stopped: PI moving on from current institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
360 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05342350
Sponsor's protocol ID
IRB00250209
Acronym
STOP-HCC
Status last verified
Jun 2025
First submitted
16 Apr 2022
Last updated
12 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Truong TN, Pham TND, Hoang LB, Nguyen VT, Dao HV, Dao DVB, Alessy S, Pham HB, Pham TTT, Nguyen LDD, Nguyen K, Abaalkhail F, Manal M, Mawardi M, AlZahrani M, Alswat K, Alghamdi H, Sanai FM, Siddiqui MA, Nguyen NH, Vaidya D, Phan HT, Johnson PJ, Alqahtani SA, Dao DY. Surveillance and treatment of primary hepatocellular carcinoma (aka. STOP HCC): protocol for a prospective cohort study of high-risk patients for HCC using GALAD-score. BMC Cancer. 2023 Sep 18;23(1):875. doi: 10.1186/s12885-023-11167-9.

    PubMed 37723439

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cancer and Liver Cirrhosis, run by Johns Hopkins University at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Saudi Arabia, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: PI moving on from current institution). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GALAD performance for liver cancer early detection (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05342350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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