{
    "info": {
        "nct_id": "NCT05052372",
        "official_title": "Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib",
        "inclusion_criteria": "* Subjects with a diagnosis of locally advanced or metastatic bladder cancer\n* Documented proof of an FGFR alteration according to a CLIA-based test\n* Subjects who are receiving or will receive erdafitinib as their standard medical therapy as a monotherapy or in combination\n* Age greater than or equal to 18 years.\n* Subject is a resident of or seeking care in the United States\n* Able and willing to provide informed consent to this biomarker study\n* Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects younger than 18 years of age\n* Subjects unwilling or unable to provide informed consent\n* Subjects that are not receiving treatment in the United States or US Territories",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Subjects with a diagnosis of locally advanced or metastatic bladder cancer",
                "criterions": [
                    {
                        "exact_snippets": "diagnosis of locally advanced or metastatic bladder cancer",
                        "criterion": "bladder cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "diagnosis of locally advanced or metastatic bladder cancer",
                        "criterion": "bladder cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Documented proof of an FGFR alteration according to a CLIA-based test",
                "criterions": [
                    {
                        "exact_snippets": "Documented proof of an FGFR alteration",
                        "criterion": "FGFR alteration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "according to a CLIA-based test",
                        "criterion": "CLIA-based test",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "CLIA-based"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Documented proof of an FGFR alteration",
                        "criterion": "FGFR alteration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "according to a CLIA-based test",
                        "criterion": "CLIA-based test",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "CLIA-based"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age greater than or equal to 18 years.",
                "criterions": [
                    {
                        "exact_snippets": "Age greater than or equal to 18 years.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age greater than or equal to 18 years.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subject is a resident of or seeking care in the United States",
                "criterions": [
                    {
                        "exact_snippets": "Subject is a resident of ... the United States",
                        "criterion": "residency",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "United States"
                        }
                    },
                    {
                        "exact_snippets": "seeking care in the United States",
                        "criterion": "seeking care location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "United States"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Subject is a resident of ... the United States",
                        "criterion": "residency",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "United States"
                        }
                    },
                    {
                        "exact_snippets": "seeking care in the United States",
                        "criterion": "seeking care location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "United States"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Able and willing to provide informed consent to this biomarker study",
                "criterions": [
                    {
                        "exact_snippets": "Able and willing to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able and willing to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Able and willing to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able and willing to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088).",
                "criterions": [
                    {
                        "exact_snippets": "Informed consent obtained",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Informed consent obtained",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Subjects younger than 18 years of age",
                "criterions": [
                    {
                        "exact_snippets": "Subjects younger than 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Subjects younger than 18 years of age",
                    "criterion": "age",
                    "requirement": {
                        "requirement_type": "value",
                        "expected_value": {
                            "operator": "<",
                            "value": 18,
                            "unit": "years"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects unwilling or unable to provide informed consent",
                "criterions": [
                    {
                        "exact_snippets": "unwilling ... to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unable to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "unwilling ... to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unable to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Subjects who are receiving or will receive erdafitinib as their standard medical therapy as a monotherapy or in combination",
                "criterions": [
                    {
                        "exact_snippets": "Subjects who are receiving or will receive erdafitinib",
                        "criterion": "erdafitinib therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "receiving",
                                "will receive"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "as a monotherapy or in combination",
                        "criterion": "erdafitinib therapy type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "monotherapy",
                                "combination"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Subjects who are receiving or will receive erdafitinib",
                                "criterion": "erdafitinib therapy",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "receiving",
                                        "will receive"
                                    ]
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "as a monotherapy or in combination",
                                        "criterion": "erdafitinib therapy type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "monotherapy"
                                        }
                                    },
                                    {
                                        "exact_snippets": "as a monotherapy or in combination",
                                        "criterion": "erdafitinib therapy type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "combination"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Subjects that are not receiving treatment in the United States or US Territories",
                "criterions": [
                    {
                        "exact_snippets": "Subjects that are not receiving treatment in the United States or US Territories",
                        "criterion": "treatment location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": {
                                "operator": "!=",
                                "value": 0,
                                "unit": "United States or US Territories"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Subjects that are not receiving treatment in the United States or US Territories",
                    "criterion": "treatment location",
                    "requirement": {
                        "requirement_type": "location",
                        "expected_value": "United States or US Territories"
                    }
                }
            }
        }
    ],
    "failed_miscellaneous": []
}