{
    "info": {
        "nct_id": "NCT02665494",
        "official_title": "Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors",
        "inclusion_criteria": "* voluntary, written, dated and signed informed consent;\n* age ≥ 18 years;\n* histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Dementia or altered mental status leading to inability to understand or render the informed consent.\n* Patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy) may be enrolled but will not be subject to data collection about BI-CAUSE - Study Protocol Version 1.0 Oct 18th, 2015 10 blood laboratory tests (with the exception of viral screening) and natural history, and will not be factored in the data analysis of prognostic factors. Performance status, life expectancy, tumour staging, tumour site (distal or hilar extrahepatic, intrahepatic), previous surgical resection, previous biliary stenting, previous radiotherapy are not part of inclusion/exclusion criteria.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* voluntary, written, dated and signed informed consent;",
            "criterions": [
                {
                    "exact_snippets": "voluntary, written, dated and signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "voluntary",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "written",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dated",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* age ≥ 18 years;",
            "criterions": [
                {
                    "exact_snippets": "age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms)",
                    "criterion": "cholangiocarcinoma diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histologically documented"
                        }
                    ]
                },
                {
                    "exact_snippets": "Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma",
                    "criterion": "neoplasms under investigation",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "gallbladder cancer",
                                "ampullary carcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Dementia or altered mental status leading to inability to understand or render the informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "altered mental status",
                    "criterion": "altered mental status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to understand or render the informed consent",
                    "criterion": "ability to understand or render informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy) may be enrolled but will not be subject to data collection about BI-CAUSE - Study Protocol Version 1.0 Oct 18th, 2015 10 blood laboratory tests (with the exception of viral screening) and natural history, and will not be factored in the data analysis of prognostic factors. Performance status, life expectancy, tumour staging, tumour site (distal or hilar extrahepatic, intrahepatic), previous surgical resection, previous biliary stenting, previous radiotherapy are not part of inclusion/exclusion criteria.",
            "criterions": [
                {
                    "exact_snippets": "Patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy)",
                    "criterion": "systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blood laboratory tests (with the exception of viral screening)",
                    "criterion": "blood laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "viral screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "inclusion/exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion/exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumour staging",
                    "criterion": "tumour staging",
                    "requirements": [
                        {
                            "requirement_type": "inclusion/exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumour site (distal or hilar extrahepatic, intrahepatic)",
                    "criterion": "tumour site",
                    "requirements": [
                        {
                            "requirement_type": "inclusion/exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous surgical resection",
                    "criterion": "previous surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "inclusion/exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous biliary stenting",
                    "criterion": "previous biliary stenting",
                    "requirements": [
                        {
                            "requirement_type": "inclusion/exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous radiotherapy",
                    "criterion": "previous radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion/exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}