International study on early detection of liver cancer using liquid biopsy

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

This study is testing a new blood test called the GALAD score to see if it can help find liver cancer early in people with liver cirrhosis who are at high risk.

Quick facts

• Study type: Observational
• Enrollment: 1600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 10 sites (Jeddah and 9 other locations)
• Trial ID: NCT05342350 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate the GALAD score, a serum biomarker panel, for early detection of hepatocellular carcinoma (HCC) in high-risk patients with liver cirrhosis. Over a period of five years, participants will undergo semi-annual abdominal ultrasounds and GALAD score assessments to monitor for signs of liver cancer. Additionally, the study will establish a biorepository of biospecimens from patients with liver fibrosis or cirrhosis to support future research. The study is being conducted in Vietnam and Saudi Arabia, regions with high liver cancer prevalence.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older with confirmed cirrhosis and a MELD score of 15 or lower, residing in Vietnam or Saudi Arabia.

Not a fit: Patients with a history of liver cancer or those currently undergoing treatment for HCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve early detection and management of liver cancer, potentially enhancing survival rates for at-risk patients.

How similar studies have performed: Previous studies have shown promising results for the GALAD score in detecting liver cancer, indicating potential for success in this validation study.

Eligibility criteria

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:

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

Where this trial is running

Jeddah and 9 other locations

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

Study contacts

• Principal investigator: Doan Dao, MD — Johns Hopkins University
• Study coordinator: Doan Y Dao, MD

Conditions Liver Cancer; Liver Cirrhosis; Hepatocellular Carcinoma; Early Stage Liver Cancer; Early detection of liver cancer; GALAD; Liver cancer; Viet Nam