{
    "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": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "according to a CLIA-based test",
                    "criterion": "CLIA-based test",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "CLIA-based"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "receiving",
                                "will receive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "as a monotherapy or in combination",
                    "criterion": "erdafitinib therapy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "monotherapy",
                                "combination"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age greater than or equal to 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age greater than or equal to 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "United States"
                        }
                    ]
                },
                {
                    "exact_snippets": "seeking care in the United States",
                    "criterion": "seeking care location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "United States"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088).",
            "criterions": [
                {
                    "exact_snippets": "Informed consent obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Subjects younger than 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Subjects younger than 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects unwilling or unable to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "unwilling ... to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": {
                                "operator": "!=",
                                "value": 0,
                                "unit": "United States or US Territories"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}