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

NCT05342350 | Terminated

• 1 other identifier: IRB00250209
• Study Type: observational
• Target: 360
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

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

Outcome Measures

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.

  5 years

Secondary Outcomes (1)

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

  5 years

Interventions

GALAD Score OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• King Faisal Specialist Hospital & Research Center: collaborator
• Medic Medical Center (Viet Nam): collaborator

Study Sites (10)

King Faisal Specialist Hospital and Research Center in Jeddah

Jeddah, Saudi Arabia

Location

National Guard Hospital in Jeddah

Jeddah, Saudi Arabia

Location

King Faisal Specialist Hospital and Research Centre in Riyadh

Riyadh, Saudi Arabia

Location

King Saud University Medical Center

Riyadh, Saudi Arabia

Location

National Guard Hospital in Riyadh

Riyadh, Saudi Arabia

Location

Binh An Hospital

Rach Gia, Kien Giang, Vietnam

Location

Medic Ca Mau

Cà Mau, Vietnam

Location

Dong Da Hospital

Hà Nội, Vietnam

Location

Institute of Gastroenterology and Hepatology

Hà Nội, Vietnam

Location

Medic Medical Center-Ho Chi Minh City

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 37723439 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Liver Neoplasms; Liver Cirrhosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Doan Dao, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 22, 2022
• Study Start: April 15, 2022
• Primary Completion: June 7, 2025
• Study Completion: June 7, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

SA (5); VN (5)