{
    "info": {
        "nct_id": "NCT02966691",
        "official_title": "Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors",
        "inclusion_criteria": "* Age ≥18 years\n* Patient affiliated to a social security system\n* Patient able to understand the protocol.\n* Signature of patient consent form before the start of the study\n* Negative urine culture\n* Patient for which is programmed a bladder Endoscopy for :\n\n  * suspected bladder cancer (de novo, monitoring or relapse)\n  * Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Age <18 years\n* Ongoing Urinary tract infection untreated\n* Private person of liberty or under guardianship (including guardianship)\n* Bladder cancer excluding urothelial carcinoma\n* Carcinoma of high urinary tract, associated\n* Lithiasis pathology\n* Patient who underwent renal transplantation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient affiliated to a social security system",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated to a social security system",
                    "criterion": "social security affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient able to understand the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Patient able to understand the protocol.",
                    "criterion": "understanding of the protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signature of patient consent form before the start of the study",
            "criterions": [
                {
                    "exact_snippets": "Signature of patient consent form",
                    "criterion": "patient consent form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative urine culture",
            "criterions": [
                {
                    "exact_snippets": "Negative urine culture",
                    "criterion": "urine culture",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient for which is programmed a bladder Endoscopy for :",
            "criterions": [
                {
                    "exact_snippets": "bladder Endoscopy",
                    "criterion": "bladder endoscopy",
                    "requirements": [
                        {
                            "requirement_type": "programmed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* suspected bladder cancer (de novo, monitoring or relapse)",
            "criterions": [
                {
                    "exact_snippets": "suspected bladder cancer",
                    "criterion": "bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "suspected"
                        }
                    ]
                },
                {
                    "exact_snippets": "de novo",
                    "criterion": "bladder cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "de novo"
                        }
                    ]
                },
                {
                    "exact_snippets": "monitoring",
                    "criterion": "bladder cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "monitoring"
                        }
                    ]
                },
                {
                    "exact_snippets": "relapse",
                    "criterion": "bladder cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "relapse"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Exploration lower urinary tract",
                    "criterion": "lower urinary tract exploration",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "suspected bladder cancer",
                                "suspected prostate cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Age <18 years",
            "criterions": [
                {
                    "exact_snippets": "Age <18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing Urinary tract infection untreated",
            "criterions": [
                {
                    "exact_snippets": "Ongoing Urinary tract infection untreated",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Private person of liberty or under guardianship (including guardianship)",
            "criterions": [
                {
                    "exact_snippets": "Private person of liberty",
                    "criterion": "liberty status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "private"
                        }
                    ]
                },
                {
                    "exact_snippets": "under guardianship (including guardianship)",
                    "criterion": "guardianship status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under guardianship"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bladder cancer excluding urothelial carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Bladder cancer",
                    "criterion": "bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding urothelial carcinoma",
                    "criterion": "urothelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Carcinoma of high urinary tract, associated",
            "criterions": [
                {
                    "exact_snippets": "Carcinoma of high urinary tract",
                    "criterion": "carcinoma of high urinary tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lithiasis pathology",
            "criterions": [
                {
                    "exact_snippets": "Lithiasis pathology",
                    "criterion": "lithiasis pathology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who underwent renal transplantation",
            "criterions": [
                {
                    "exact_snippets": "underwent renal transplantation",
                    "criterion": "renal transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}