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TerminatedNCT05342350STOP-HCCUpdated Jun 12, 2025

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

An observational study in Liver Cancer, Liver Cirrhosis and Hepatocellular Carcinoma, sponsored by Johns Hopkins University. Terminated at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.

Sponsored by Johns Hopkins University · Observational

Why this study was terminated
PI moving on from current institution
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
360
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Liver Cancer
  • Liver Cirrhosis
  • Hepatocellular Carcinoma
  • Early Stage Liver Cancer

Keywords

  • Early detection of liver cancer
  • GALAD
  • Liver cancer
  • Viet Nam
  • Saudi Arabia
  • Liver cirrhosis
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 360 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  1. Provision of signed and dated informed consent form
  2. 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
  3. Adults aged 18 or older
  4. Both genders and all ethnicities
  5. Willingness to give written, informed consent to be enrolled into the database
  6. Collection of biosamples (serum, plasma, and urine) at each of the 6 months follow up during the study duration
  7. Individuals already confirmed to have cirrhosis with MELD ≤ 15 from any etiology (chronic HBV, chronic HCV, NASH cirrhosis, etc.)
  8. For chronic HBV and/or /HCV carrier, with or without on treatment
  9. Reside in Vietnam or Saudi Arabia at the time of study and provides contact information (email and/or cell phone number for texting)
  10. No prior or current treatment of HCC
  11. No cancer history within 5 years
  12. No participation in a trial for HCC Treatment
  13. No prior solid organ transplant
  14. Albumin, Bilirubin, Creatinine and INR labs within past 30 days
  15. Imaging showing no HCC within 180 days
  16. 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)
  17. No significant hepatic decompensation
  18. No hepatorenal syndrome
  19. AFP labs within 180 days irrespective of AFP titer
  20. Two phone numbers and personal identification numbers (CMND number)
  21. No known AIDS related diseases
  22. No significant co-morbid conditions with life expectancy \<5 years
  23. No other cancer(s)

Exclusion criteria

Exclusion Criteria:

  1. Decompensated cirrhosis (variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, and/or hepatorenal syndrome) or MELD>15
  2. Individuals who already have HCC, with or without HCC treatment
  3. On liver transplantation list or anticipated to be on the liver transplantation list during the study duration
  4. Individuals who cannot, do not want to, or refused to sign the informed consent form (ICF)
  5. 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
  6. Documentation was not adequate
  7. Taking Vitamin K within 7 days prior to clinic follow or having disease affecting Vitamin K levels.
  8. Known HIV positive
  9. Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
360 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • OtherGALAD Score

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 5 years

Secondary outcomes

  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

    Time frame: 5 years

07

Study locations

10 sites
  • King Faisal Specialist Hospital and Research Center in Jeddah
    Jeddah, Saudi Arabia
  • National Guard Hospital in Jeddah
    Jeddah, Saudi Arabia
  • King Faisal Specialist Hospital and Research Centre in Riyadh
    Riyadh, Saudi Arabia
  • King Saud University Medical Center
    Riyadh, Saudi Arabia
  • National Guard Hospital in Riyadh
    Riyadh, Saudi Arabia
  • Binh An Hospital
    Rach Gia, Kien Giang, Vietnam
  • Medic Ca Mau
    Ca Mau, Vietnam
  • Dong Da Hospital
    Ha Noi, Vietnam
  • Institute of Gastroenterology and Hepatology
    Ha Noi, Vietnam
  • Medic Medical Center-Ho Chi Minh City
    Ho Chi Minh City, Vietnam
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05342350
Lead sponsor
Johns Hopkins University
Collaborators
King Faisal Specialist Hospital & Research Center, Medic Medical Center (Viet Nam)
Responsible party
Sponsor
First posted
Apr 22, 2022
Start date
Apr 15, 2022
Primary completion
Jun 7, 2025
Completion
Jun 7, 2025
Last update
Jun 12, 2025

Study contacts

Doan Dao, MD
principal investigator · Johns Hopkins University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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