{
    "info": {
        "nct_id": "NCT05902494",
        "official_title": "A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression",
        "inclusion_criteria": "* Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type.\n* Locally advanced unresectable or metastatic stage disease\n* Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.\n* At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing chemotherapy.\n* Initiation of anticancer therapy for UC after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the end of data collection\n* Radiographically documented and measurable disease progression immediately before index date\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Any concurrent malignant neoplasm requiring systemic therapy during the study window\n* Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed UC",
                    "criterion": "urothelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "originating from the renal pelvis, ureters, bladder, or urethra",
                    "criterion": "tumor origin",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "renal pelvis",
                                "ureters",
                                "bladder",
                                "urethra"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Mixed-cell type tumors are eligible ... urothelial cell carcinoma is the predominant cell type",
                    "criterion": "tumor cell type",
                    "requirements": [
                        {
                            "requirement_type": "predominance",
                            "expected_value": "urothelial cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced unresectable or metastatic stage disease",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced unresectable",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced unresectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic stage disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.",
            "criterions": [
                {
                    "exact_snippets": "Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.",
                    "criterion": "FFPE tumor tissue blocks or freshly sectioned slides",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 testing",
                    "criterion": "HER2 testing",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC)",
                    "criterion": "prior line of systemic therapy for LA/mUC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including 1 line of platinum-containing chemotherapy",
                    "criterion": "prior line of platinum-containing chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Initiation of anticancer therapy for UC after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the end of data collection",
            "criterions": [
                {
                    "exact_snippets": "Initiation of anticancer therapy for UC after prior progression on platinum-based therapy",
                    "criterion": "anticancer therapy initiation",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "prior progression on platinum-based therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Initiation of anticancer therapy for UC ... with or without maintenance avelumab",
                    "criterion": "maintenance avelumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "with or without"
                        }
                    ]
                },
                {
                    "exact_snippets": "Initiation of anticancer therapy for UC ... between 01 January 2019 and 12 months before the end of data collection",
                    "criterion": "anticancer therapy initiation date",
                    "requirements": [
                        {
                            "requirement_type": "date range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2019,
                                        "unit": "year"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months before end of data collection"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiographically documented and measurable disease progression immediately before index date",
            "criterions": [
                {
                    "exact_snippets": "Radiographically documented",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "radiographically"
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immediately before index date",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "immediately before index date"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Any concurrent malignant neoplasm requiring systemic therapy during the study window",
            "criterions": [
                {
                    "exact_snippets": "concurrent malignant neoplasm requiring systemic therapy",
                    "criterion": "concurrent malignant neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy",
            "criterions": [
                {
                    "exact_snippets": "Enrollment in a therapeutic clinical trial",
                    "criterion": "therapeutic clinical trial enrollment",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received non-standard of care treatment during index line of therapy",
                    "criterion": "non-standard of care treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}