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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT01446666
Eligibility Criteria:
Inclusion Criteria:
Patients with liver cirrhosis with the 1 year risk of HCC of 5% or higher meeting all of following criteria;
1. The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
* 1\) Histologically by liver biopsy;
* 2\) Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
* Evidence of portal hypertension, including any of followings;
1. The identification of splenomegaly on USG, CT, or MRI examinations with typical features of cirrhosis
2. The identification of esophageal or gastric varices on endoscopic examination
2. High Risk Index (\>=2.33); Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus \[HCV\] or hepatitis B surface antigen \[HBsAg\] is positive).
3. Older than 20 years of age
4. Absence of previous or current history of HCC
5. Absence of HCC should be identified by liver USG, dynamic CT, or contrast-enhanced MRI within 6 months prior to screening
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
7. Patient is able to comply with scheduled visits, evaluation plans, and other study procedures.
8. Patient is willing to provide written informed consent
Exclusion Criteria:
Presence of any of following criteria;
1. Active or suspected cancer other than HCC, or a history of malignancy where the risk of recurrence is \>20% within 2 years
2. Child-Pugh score \>9
3. Significant medical comorbidities in which survival is predicted to be less than 3 years
4. Estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73m2
5. Precautions for MRI (cardiac pacemaker, ferromagnetic implants, etc.)
6. Severe claustrophobia that may interfere with protocol compliance.
7. Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completing the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01446666
Study Brief:
Protocol Section:
NCT01446666