{
    "info": {
        "nct_id": "NCT04896931",
        "official_title": "New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)",
        "inclusion_criteria": "* Known biliary-tract cancer including intrahepatic-, extrahepatic- and gallbladder carcinomas\n* age ≥18 years\n* signed informed consent form\n* planned for (or recently started - i.e. within the last 21 days)) neoadjuvant, adjuvant or 1st line therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who are unable to consent because they do not understand the nature, significance and implications of the registry and therefore cannot form a rational intention\n* Patient under 18 years of age\n* Patient's inability to complete QoL questionnaire or answer the questions.\n* Second-line or further palliative therapies if the patient's first-line therapy was not documented within the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Known biliary-tract cancer including intrahepatic-, extrahepatic- and gallbladder carcinomas",
            "criterions": [
                {
                    "exact_snippets": "Known biliary-tract cancer",
                    "criterion": "biliary-tract cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intrahepatic-",
                    "criterion": "intrahepatic carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extrahepatic-",
                    "criterion": "extrahepatic carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gallbladder carcinomas",
                    "criterion": "gallbladder carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* age ≥18 years",
            "criterions": [
                {
                    "exact_snippets": "age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* signed informed consent form",
            "criterions": [
                {
                    "exact_snippets": "signed informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* planned for (or recently started - i.e. within the last 21 days)) neoadjuvant, adjuvant or 1st line therapy",
            "criterions": [
                {
                    "exact_snippets": "planned for (or recently started - i.e. within the last 21 days)) neoadjuvant, adjuvant or 1st line therapy",
                    "criterion": "therapy type",
                    "requirements": [
                        {
                            "requirement_type": "planned or recently started",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant",
                                "1st line"
                            ]
                        },
                        {
                            "requirement_type": "recently started",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients who are unable to consent because they do not understand the nature, significance and implications of the registry and therefore cannot form a rational intention",
            "criterions": [
                {
                    "exact_snippets": "unable to consent because they do not understand the nature, significance and implications of the registry",
                    "criterion": "ability to consent",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient under 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "under 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient's inability to complete QoL questionnaire or answer the questions.",
            "criterions": [
                {
                    "exact_snippets": "Patient's inability to complete QoL questionnaire",
                    "criterion": "ability to complete QoL questionnaire",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient's inability to ... answer the questions",
                    "criterion": "ability to answer questions",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Second-line or further palliative therapies if the patient's first-line therapy was not documented within the study.",
            "criterions": [
                {
                    "exact_snippets": "Second-line or further palliative therapies",
                    "criterion": "palliative therapies",
                    "requirements": [
                        {
                            "requirement_type": "line of therapy",
                            "expected_value": "second-line or further"
                        }
                    ]
                },
                {
                    "exact_snippets": "if the patient's first-line therapy was not documented within the study",
                    "criterion": "first-line therapy documentation",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}