Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT05342350
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
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05342350
Study Brief:
Protocol Section:
NCT05342350