Phase
Condition
Abdominal Cancer
Digestive System Neoplasms
Cancer/tumors
Treatment
GALAD Score
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for theduration 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 followup 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 contactinformation (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 cirrhoticliver with splenomegaly and platelets <120 mm3, or esophageal or gastric varices onendoscopy AND presence of chronic liver disease/Fibroscan/Fib-4/APRI/ARFI. For viralhepatitis, 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
Exclusion Criteria:
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 listduring 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 theinvestigator, would interfere with patient treatment, assessment or compliance withthe protocol
Documentation was not adequate
Taking Vitamin K within 7 days prior to clinic follow or having disease affectingVitamin K levels.
Known HIV positive
Active drug use or dependence that, in the opinion of the study investigator, wouldinterfere with adherence to study requirements
Study Design
Study Description
Connect with a study center
King Faisal Specialist Hospital and Research Center in Jeddah
Jeddah,
Saudi ArabiaActive - Recruiting
National Guard Hospital in Jeddah
Jeddah,
Saudi ArabiaActive - Recruiting
King Faisal Specialist Hospital and Research Centre in Riyadh
Riyadh,
Saudi ArabiaActive - Recruiting
King Saud University Medical Center
Riyadh,
Saudi ArabiaSite Not Available
National Guard Hospital in Riyadh
Riyadh,
Saudi ArabiaSite Not Available
Binh An Hospital
Rach Gia, Kien Giang
VietnamSite Not Available
Medic Ca Mau
Ca Mau,
VietnamSite Not Available
Dong Da Hospital
Ha Noi,
VietnamSite Not Available
Institute of Gastroenterology and Hepatology
Ha Noi,
VietnamSite Not Available
Medic Medical Center-Ho Chi Minh City
Ho Chi Minh City,
VietnamSite Not Available
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