{
"info": {
"nct_id": "NCT02075060",
"official_title": "",
"inclusion_criteria": "* Age > 18 years,\n* Primary or recurrent bladder tumor with endoscopic papillary aspect,\n* One or two bladder tumors,\n* Cytology before TURB showing no high-grade cells,\n* Patients without tutorship or subordination (ou curatorship),\n* Patients under the general social security system or qualifying through a third party,\n* Informed consent signed by the patient after clear and fair information.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Age < 18 years,\n* Allergy to mitomycin C,\n* Traumatic stenting,\n* Upper tract urothelial cancer,\n* Urethral invasion,\n* History of muscle invasive bladder cancer,\n* Extensive tumor (3 cm or more),\n* Any contraindication to TURB,\n* Simultaneous participation in another clinical research study,\n* Patients not insured by the social security or not qualifying through a third party,\n* Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations,\n* Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).",
"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": "* Primary or recurrent bladder tumor with endoscopic papillary aspect,",
"criterions": [
{
"exact_snippets": "Primary or recurrent bladder tumor",
"criterion": "bladder tumor",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"primary",
"recurrent"
]
}
]
},
{
"exact_snippets": "endoscopic papillary aspect",
"criterion": "tumor aspect",
"requirements": [
{
"requirement_type": "appearance",
"expected_value": "endoscopic papillary"
}
]
}
]
},
{
"line": "* One or two bladder tumors,",
"criterions": [
{
"exact_snippets": "One or two bladder tumors",
"criterion": "bladder tumors",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "=",
"value": 1,
"unit": "N/A"
},
{
"operator": "=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Cytology before TURB showing no high-grade cells,",
"criterions": [
{
"exact_snippets": "Cytology before TURB showing no high-grade cells",
"criterion": "cytology before TURB",
"requirements": [
{
"requirement_type": "presence of high-grade cells",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients without tutorship or subordination (ou curatorship),",
"criterions": [
{
"exact_snippets": "Patients without tutorship or subordination (ou curatorship)",
"criterion": "tutorship or subordination",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients under the general social security system or qualifying through a third party,",
"criterions": [
{
"exact_snippets": "Patients under the general social security system",
"criterion": "social security system",
"requirements": [
{
"requirement_type": "enrollment",
"expected_value": "general"
}
]
},
{
"exact_snippets": "qualifying through a third party",
"criterion": "third party qualification",
"requirements": [
{
"requirement_type": "qualification",
"expected_value": true
}
]
}
]
},
{
"line": "* Informed consent signed by the patient after clear and fair information.",
"criterions": [
{
"exact_snippets": "Informed consent signed by the patient",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
},
{
"exact_snippets": "after clear and fair information",
"criterion": "information provided",
"requirements": [
{
"requirement_type": "clarity and fairness",
"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": "* Age < 18 years,",
"criterions": [
{
"exact_snippets": "Age < 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Allergy to mitomycin C,",
"criterions": [
{
"exact_snippets": "Allergy to mitomycin C",
"criterion": "allergy",
"requirements": [
{
"requirement_type": "substance",
"expected_value": "mitomycin C"
}
]
}
]
},
{
"line": "* Traumatic stenting,",
"criterions": [
{
"exact_snippets": "Traumatic stenting",
"criterion": "traumatic stenting",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Upper tract urothelial cancer,",
"criterions": [
{
"exact_snippets": "Upper tract urothelial cancer",
"criterion": "upper tract urothelial cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Urethral invasion,",
"criterions": [
{
"exact_snippets": "Urethral invasion",
"criterion": "urethral invasion",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of muscle invasive bladder cancer,",
"criterions": [
{
"exact_snippets": "History of muscle invasive bladder cancer",
"criterion": "muscle invasive bladder cancer",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Extensive tumor (3 cm or more),",
"criterions": [
{
"exact_snippets": "Extensive tumor (3 cm or more)",
"criterion": "tumor size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "cm"
}
}
]
}
]
},
{
"line": "* Any contraindication to TURB,",
"criterions": [
{
"exact_snippets": "Any contraindication to TURB",
"criterion": "contraindication to TURB",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Simultaneous participation in another clinical research study,",
"criterions": [
{
"exact_snippets": "Simultaneous participation in another clinical research study",
"criterion": "simultaneous participation in another clinical research study",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients not insured by the social security or not qualifying through a third party,",
"criterions": [
{
"exact_snippets": "Patients not insured by the social security",
"criterion": "insurance status",
"requirements": [
{
"requirement_type": "coverage",
"expected_value": "not insured by the social security"
}
]
},
{
"exact_snippets": "not qualifying through a third party",
"criterion": "insurance qualification",
"requirements": [
{
"requirement_type": "qualification",
"expected_value": "not qualifying through a third party"
}
]
}
]
},
{
"line": "* Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations,",
"criterions": [
{
"exact_snippets": "pregnant or lactating women",
"criterion": "pregnancy or lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "persons deprived of their liberty by a judicial or administrative decision",
"criterion": "deprivation of liberty",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "people staying in a health or social institution",
"criterion": "residence in health or social institution",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "adults under legal protection",
"criterion": "legal protection status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "patients in emergency situations",
"criterion": "emergency situation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactating",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "women of childbearing potential not willing to use an adequate method of birth control",
"criterion": "willingness to use birth control",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}