Status:
TERMINATED
International Study of High-Risk Patients for Hepatocellular Carcinoma Using Liquid Biopsy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
King Faisal Specialist Hospital & Research Center
Medic Medical Center (Viet Nam)
Conditions:
Liver Cancer
Liver Cirrhosis
Eligibility:
All Genders
18+ years
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-annua...
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 outcome...
Eligibility Criteria
Inclusion
- 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
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 7 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05342350
Start Date
April 15 2022
End Date
June 7 2025
Last Update
June 12 2025
Active Locations (10)
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1
King Faisal Specialist Hospital and Research Center in Jeddah
Jeddah, Saudi Arabia
2
National Guard Hospital in Jeddah
Jeddah, Saudi Arabia
3
King Faisal Specialist Hospital and Research Centre in Riyadh
Riyadh, Saudi Arabia
4
King Saud University Medical Center
Riyadh, Saudi Arabia