{
    "info": {
        "nct_id": "NCT02345473",
        "official_title": "Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy",
        "inclusion_criteria": "* Prior trans urethral resection of the bladder (TUR)\n* Histological confirmation of a transitional cell carcinoma (TCC) of the bladder\n* ECOG Performance Status ≤ 2\n* WBC count ≥4,000/μL; platelet count ≥150,000/μL; creatinine ≤1.8 mg/dL; AST, ALT, and alkaline phosphatase ≤2X the upper limit of normal, normal total bilirubin\n* recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Neo-adjuvant chemotherapy (either planned or already performed)\n* Patients receiving investigational medications\n* Subjects not suitable for a radical cystectomy\n* Patients not willing to participate",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Prior trans urethral resection of the bladder (TUR)",
            "criterions": [
                {
                    "exact_snippets": "Prior trans urethral resection of the bladder (TUR)",
                    "criterion": "trans urethral resection of the bladder (TUR)",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological confirmation of a transitional cell carcinoma (TCC) of the bladder",
            "criterions": [
                {
                    "exact_snippets": "Histological confirmation of a transitional cell carcinoma (TCC) of the bladder",
                    "criterion": "transitional cell carcinoma (TCC) of the bladder",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status ≤ 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status ≤ 2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC count ≥4,000/μL; platelet count ≥150,000/μL; creatinine ≤1.8 mg/dL; AST, ALT, and alkaline phosphatase ≤2X the upper limit of normal, normal total bilirubin",
            "criterions": [
                {
                    "exact_snippets": "WBC count ≥4,000/μL",
                    "criterion": "WBC count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4000,
                                "unit": "μL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥150,000/μL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 150000,
                                "unit": "μL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine ≤1.8 mg/dL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.8,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST, ALT, and alkaline phosphatase ≤2X the upper limit of normal",
                    "criterion": "AST, ALT, and alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "≤2X the upper limit of normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal total bilirubin",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC",
            "criterions": [
                {
                    "exact_snippets": "recent (within 6 weeks of cystectomy) total body CT imaging study",
                    "criterion": "total body CT imaging study",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... upper urinary tract TCC",
                    "criterion": "upper urinary tract TCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Neo-adjuvant chemotherapy (either planned or already performed)",
            "criterions": [
                {
                    "exact_snippets": "Neo-adjuvant chemotherapy (either planned or already performed)",
                    "criterion": "neo-adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "planned",
                                "already performed"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving investigational medications",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving investigational medications",
                    "criterion": "investigational medications",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects not suitable for a radical cystectomy",
            "criterions": [
                {
                    "exact_snippets": "Subjects not suitable for a radical cystectomy",
                    "criterion": "suitability for radical cystectomy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients not willing to participate",
            "criterions": [
                {
                    "exact_snippets": "not willing to participate",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}