{
    "info": {
        "nct_id": "NCT05541601",
        "official_title": "Prospective Cohort for Early Detection of Liver Cancer",
        "inclusion_criteria": "1. Patients of all genders, age >18 years\n2. Participant is willing and able to give informed consent for participation in the study.\n3. Evidence of cirrhosis CP A or B (as defined below, cirrhosis ever diagnosed), with an underlying aetiology of at least one of the following: chronic Hepatitis B Virus (HBV) infection, chronic Hepatitis C Virus (HCV) infection, alcoholic liver disease, non-alcoholic fatty liver disease or haemochromatosis\n\nCirrhosis Diagnosis Definition\n\n1. Histological assessment (Ishak stage 5 or 6) or\n2. At least one of the following:\n\ni. Validated non-invasive marker of fibrosis including fibroscan, AST to Platelet Ratio Index (APRI) score >2 or Enhanced Liver Fibrosis (ELF) score >10.48 or Fibrotest score >0.73. Fibroscan readings should be assessed by aetiology as below:\n\n* HBV: >=10 kPa\n* HCV: >=14.5 kPa\n* Alcoholic Liver Disease (ALD): >=19.5 kPa\n* Non-alcoholic fatty liver disease (NAFLD): >=15 kPa\n* Haemochromatosis: >=12kPa ii. Evidence of varices at endoscopy or imaging in the context of a patent portal vein iii. Definitive radiological evidence of cirrhosis (i.e. nodularity of liver and splenomegaly on Ultrasound/CT)\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "1. Diagnosis of current OR historical hepatocellular carcinoma\n2. Liver transplant recipients or patients on active listing for liver transplantation\n3. Child-Pugh C cirrhosis\n4. In the view of the clinician, if the patient has a co-morbidity likely to lead to death within the following 12 months\n5. In the view of the clinician, if the patient was not thought to be suitable for HCC surveillance",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients of all genders, age >18 years",
            "criterions": [
                {
                    "exact_snippets": "Patients of all genders",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "male",
                                "female",
                                "other"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "age >18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participant is willing and able to give informed consent for participation in the study.",
            "criterions": [
                {
                    "exact_snippets": "Participant is willing and able to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Evidence of cirrhosis CP A or B (as defined below, cirrhosis ever diagnosed), with an underlying aetiology of at least one of the following: chronic Hepatitis B Virus (HBV) infection, chronic Hepatitis C Virus (HCV) infection, alcoholic liver disease, non-alcoholic fatty liver disease or haemochromatosis",
            "criterions": [
                {
                    "exact_snippets": "Evidence of cirrhosis CP A or B",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "CP A",
                                "CP B"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cirrhosis ever diagnosed",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "underlying aetiology of at least one of the following: chronic Hepatitis B Virus (HBV) infection",
                    "criterion": "underlying aetiology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "chronic Hepatitis B Virus (HBV) infection"
                        }
                    ]
                },
                {
                    "exact_snippets": "underlying aetiology of at least one of the following: ... chronic Hepatitis C Virus (HCV) infection",
                    "criterion": "underlying aetiology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "chronic Hepatitis C Virus (HCV) infection"
                        }
                    ]
                },
                {
                    "exact_snippets": "underlying aetiology of at least one of the following: ... alcoholic liver disease",
                    "criterion": "underlying aetiology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "alcoholic liver disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "underlying aetiology of at least one of the following: ... non-alcoholic fatty liver disease",
                    "criterion": "underlying aetiology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "non-alcoholic fatty liver disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "underlying aetiology of at least one of the following: ... haemochromatosis",
                    "criterion": "underlying aetiology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "haemochromatosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cirrhosis Diagnosis Definition",
            "criterions": [
                {
                    "exact_snippets": "Cirrhosis Diagnosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Histological assessment (Ishak stage 5 or 6) or",
            "criterions": [
                {
                    "exact_snippets": "Histological assessment (Ishak stage 5 or 6)",
                    "criterion": "Ishak stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "5",
                                "6"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "i. Validated non-invasive marker of fibrosis including fibroscan, AST to Platelet Ratio Index (APRI) score >2 or Enhanced Liver Fibrosis (ELF) score >10.48 or Fibrotest score >0.73. Fibroscan readings should be assessed by aetiology as below:",
            "criterions": [
                {
                    "exact_snippets": "fibroscan",
                    "criterion": "fibroscan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "AST to Platelet Ratio Index (APRI) score >2",
                    "criterion": "AST to Platelet Ratio Index (APRI) score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Enhanced Liver Fibrosis (ELF) score >10.48",
                    "criterion": "Enhanced Liver Fibrosis (ELF) score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 10.48,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Fibrotest score >0.73",
                    "criterion": "Fibrotest score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.73,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HBV: >=10 kPa",
            "criterions": [
                {
                    "exact_snippets": "HBV: >=10 kPa",
                    "criterion": "HBV",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "kPa"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HCV: >=14.5 kPa",
            "criterions": [
                {
                    "exact_snippets": "HCV: >=14.5 kPa",
                    "criterion": "HCV",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14.5,
                                "unit": "kPa"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alcoholic Liver Disease (ALD): >=19.5 kPa",
            "criterions": [
                {
                    "exact_snippets": "Alcoholic Liver Disease (ALD): >=19.5 kPa",
                    "criterion": "Alcoholic Liver Disease (ALD)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19.5,
                                "unit": "kPa"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-alcoholic fatty liver disease (NAFLD): >=15 kPa",
            "criterions": [
                {
                    "exact_snippets": "Non-alcoholic fatty liver disease (NAFLD): >=15 kPa",
                    "criterion": "Non-alcoholic fatty liver disease (NAFLD)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "kPa"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Haemochromatosis: >=12kPa ii. Evidence of varices at endoscopy or imaging in the context of a patent portal vein iii. Definitive radiological evidence of cirrhosis (i.e. nodularity of liver and splenomegaly on Ultrasound/CT)",
            "criterions": [
                {
                    "exact_snippets": "Haemochromatosis: >=12kPa",
                    "criterion": "haemochromatosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "kPa"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of varices at endoscopy or imaging",
                    "criterion": "varices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patent portal vein",
                    "criterion": "portal vein",
                    "requirements": [
                        {
                            "requirement_type": "patency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Definitive radiological evidence of cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "definitive radiological"
                        }
                    ]
                },
                {
                    "exact_snippets": "nodularity of liver",
                    "criterion": "liver nodularity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "splenomegaly on Ultrasound/CT",
                    "criterion": "splenomegaly",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Diagnosis of current OR historical hepatocellular carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of current OR historical hepatocellular carcinoma",
                    "criterion": "hepatocellular carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "current",
                                "historical"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Liver transplant recipients or patients on active listing for liver transplantation",
            "criterions": [
                {
                    "exact_snippets": "Liver transplant recipients",
                    "criterion": "liver transplant recipient",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients on active listing for liver transplantation",
                    "criterion": "active listing for liver transplantation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Child-Pugh C cirrhosis",
            "criterions": [
                {
                    "exact_snippets": "Child-Pugh C cirrhosis",
                    "criterion": "Child-Pugh classification",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "C"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. In the view of the clinician, if the patient has a co-morbidity likely to lead to death within the following 12 months",
            "criterions": [
                {
                    "exact_snippets": "co-morbidity likely to lead to death within the following 12 months",
                    "criterion": "co-morbidity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "likely to lead to death within the following 12 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. In the view of the clinician, if the patient was not thought to be suitable for HCC surveillance",
            "criterions": [
                {
                    "exact_snippets": "patient was not thought to be suitable for HCC surveillance",
                    "criterion": "suitability for HCC surveillance",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "2. At least one of the following:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}