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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT02272504
Eligibility Criteria:
Inclusion Criteria:
* Patient who is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
* Patients with a clinical suspicion of cirrhosis based on the investigator's evaluation with cirrhosis confirmed by one of the following: (see below for definition of cirrhosis). Etiology of cirrhosis will not be considered in determining inclusion in the study.
* Patients aged 18 years and older.
* Hep B Risk Score \> 8 (table 1)
Table 1 Variable Risk Score Variable Risk Score Male 2 ALT \<15 0 Female 0 ALT 15-44 1 Age 30-34 0 ALT \> 45 2 Age 35-39 1 HBeAg+ve 0 Age 40-44 2 Anti-HBe-positive 2 Age 45-49 3 HBV DNA \<300 copies/mL 0 Age 50-54 4 HBV DNA 300-9999 copies/mL 0 Age 55-59 5 HBV DNA 104 -99,000 copies/mL 3 Age 60-65 6 HBV DNA 105 - 999,999 copies/mL 5 HBV DNA \> 106 copies/mL 4
Exclusion Criteria:
* • Patients who have confirmed HCC by CT/MRI when they enrolled. Patients who have previously had HCC but have been treated and have been recurrence free for 5 years are eligible.
* Patients with the other cancer(s)
* Pregnant Women
* Patients who have known diagnosis of mental incapacitation that affects their ability to consent.
* Patients who are likely to be transplanted within 1 year or MELD score greater than 20.
* Patients with total or direct bilirubin \> 3x upper limit of normal
* Patients with uncontrollable ascites
* Glomerular Filtration Rate less than 60.
* Patients with ≥ Grade II of hepatic encephalopathy
* Patients who are being treated with warfarin (DCP test values are affected by warfarin)
* Patients who have any contraindication to any of the study procedures, products used or its constituents (e.g., renal failure or contrast allergy).
* Patients who suffer from claustrophobia or who have other contraindications to MRI
* Patients with cirrhosis who were successfully treated for hepatitis C more than 3 years prior. However, patients who are on study who are treated for their hepatitis C may continue in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02272504
Study Brief:
Protocol Section:
NCT02272504