{
    "info": {
        "nct_id": "NCT02070120",
        "official_title": "CALIBER - A Phase II Randomised Feasibility Study of Chemoresection and Surgical Management in Low Risk Non Muscle Invasive Bladder Cancer",
        "inclusion_criteria": "* Written informed consent\n* NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of ≤6 using EORTC risk tables\n* Histologically confirmed Transitional-cell carcinoma (TCC) at original diagnosis\n* Aged 16 or over\n* Satisfactory pre-treatment haematology values and serum creatinine < 1.5 x Upper Limit of Normal (ULN)\n* Negative pregnancy test for women of child-bearing potential\nHealthy volunteers allowed\nMust have minimum age of 16 Years",
        "exclusion_criteria": "* Any history of: grade 3/high grade or ≥T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter\n* Any history of histologically confirmed non-TCC bladder cancer\n* Trial entry recurrence identified within 11.5 months of the date of the original diagnosis\n* Any prior treatment of the trial entry recurrence (including biopsy)\n* Previous MMC chemotherapy other than a single instillation at diagnostic surgery\n* Known allergy to MMC\n* Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)\n* Known or suspected reduced bladder capacity (<100ml)\n* Significant bleeding disorder\n* Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active.\n* Active or intractable urinary tract infection\n* Urethral stricture or anything impeding the insertion of a catheter\n* Large narrow neck diverticula\n* Significant urinary incontinence\n* Any other conditions that in the Principal Investigator's opinion would contraindicate protocol treatment\n* Unable or unwilling to comply with study procedures or follow up schedule",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of ≤6 using EORTC risk tables",
            "criterions": [
                {
                    "exact_snippets": "NMIBC recurrence following original diagnosis of low risk NMIBC",
                    "criterion": "NMIBC recurrence",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "following original diagnosis of low risk NMIBC"
                        }
                    ]
                },
                {
                    "exact_snippets": "original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade)",
                    "criterion": "original diagnosis of low risk NMIBC",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": [
                                "Ta G1",
                                "Ta G2",
                                "Ta low grade"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "risk of recurrence score of ≤6 using EORTC risk tables",
                    "criterion": "risk of recurrence score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "EORTC risk tables"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed Transitional-cell carcinoma (TCC) at original diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed Transitional-cell carcinoma (TCC)",
                    "criterion": "Transitional-cell carcinoma (TCC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "original diagnosis",
                    "criterion": "original diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aged 16 or over",
            "criterions": [
                {
                    "exact_snippets": "Aged 16 or over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Satisfactory pre-treatment haematology values and serum creatinine < 1.5 x Upper Limit of Normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Satisfactory pre-treatment haematology values",
                    "criterion": "pre-treatment haematology values",
                    "requirements": [
                        {
                            "requirement_type": "satisfaction",
                            "expected_value": "satisfactory"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine < 1.5 x Upper Limit of Normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test for women of child-bearing potential",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test for women of child-bearing potential",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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 16 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 16 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Any history of: grade 3/high grade or ≥T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter",
            "criterions": [
                {
                    "exact_snippets": "Any history of: grade 3/high grade or ≥T1 transitional cell carcinoma",
                    "criterion": "transitional cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "grade 3",
                                "high grade"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "T"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any history of: ... concomitant carcinoma in situ",
                    "criterion": "carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any history of: ... more than 7 tumours at one diagnosis",
                    "criterion": "number of tumours at one diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "tumours"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any history of: ... more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter",
                    "criterion": "recurrence rate",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "recurrences per year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any history of histologically confirmed non-TCC bladder cancer",
            "criterions": [
                {
                    "exact_snippets": "Any history of histologically confirmed non-TCC bladder cancer",
                    "criterion": "non-TCC bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Trial entry recurrence identified within 11.5 months of the date of the original diagnosis",
            "criterions": [
                {
                    "exact_snippets": "recurrence identified within 11.5 months of the date of the original diagnosis",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "time since original diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 11.5,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any prior treatment of the trial entry recurrence (including biopsy)",
            "criterions": [
                {
                    "exact_snippets": "Any prior treatment of the trial entry recurrence",
                    "criterion": "prior treatment of trial entry recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous MMC chemotherapy other than a single instillation at diagnostic surgery",
            "criterions": [
                {
                    "exact_snippets": "Previous MMC chemotherapy other than a single instillation at diagnostic surgery",
                    "criterion": "MMC chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": "other than a single instillation at diagnostic surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known allergy to MMC",
            "criterions": [
                {
                    "exact_snippets": "Known allergy to MMC",
                    "criterion": "allergy to MMC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)",
            "criterions": [
                {
                    "exact_snippets": "Carcinoma involving the prostatic urethra",
                    "criterion": "carcinoma in prostatic urethra",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Carcinoma involving the ... upper urinary tract",
                    "criterion": "carcinoma in upper urinary tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging of the upper urinary tract within 2 years prior to randomisation",
                    "criterion": "imaging of upper urinary tract",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 years prior to randomisation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known or suspected reduced bladder capacity (<100ml)",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected reduced bladder capacity (<100ml)",
                    "criterion": "bladder capacity",
                    "requirements": [
                        {
                            "requirement_type": "capacity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant bleeding disorder",
            "criterions": [
                {
                    "exact_snippets": "Significant bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active.",
            "criterions": [
                {
                    "exact_snippets": "Female patients who are breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients ... of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients ... unwilling or unable to use adequate non-hormonal contraception",
                    "criterion": "use of non-hormonal contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Male patients should also use contraception if sexually active",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active or intractable urinary tract infection",
            "criterions": [
                {
                    "exact_snippets": "Active or intractable urinary tract infection",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "intractable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urethral stricture or anything impeding the insertion of a catheter",
            "criterions": [
                {
                    "exact_snippets": "Urethral stricture",
                    "criterion": "urethral stricture",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anything impeding the insertion of a catheter",
                    "criterion": "impediment to catheter insertion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Large narrow neck diverticula",
            "criterions": [
                {
                    "exact_snippets": "Large narrow neck diverticula",
                    "criterion": "diverticula",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": "large"
                        },
                        {
                            "requirement_type": "neck type",
                            "expected_value": "narrow"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant urinary incontinence",
            "criterions": [
                {
                    "exact_snippets": "Significant urinary incontinence",
                    "criterion": "urinary incontinence",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other conditions that in the Principal Investigator's opinion would contraindicate protocol treatment",
            "criterions": [
                {
                    "exact_snippets": "Any other conditions ... contraindicate protocol treatment",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable or unwilling to comply with study procedures or follow up schedule",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to comply with study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Unable or unwilling to ... follow up schedule",
                    "criterion": "compliance with follow up schedule",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}