{
"info": {
"nct_id": "NCT02562729",
"official_title": "A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study",
"inclusion_criteria": "* Age >=18 years to <= 70 years.\n* Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix.\n* Stage IIA1, or IB1 disease.\n* Karnofsky performance status >70.\n* Patients who comply with follow-up.\n* With written informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* Age>70\n* History of lower urinary tract damage or surgery.\n* With abnormal urodynamic study results.\n* Karnofsky performance status <70.\n* Patients who have uncontrolled psychological disorders.\n* Unwilling to or unable to comply with protocol.\n* Prior treatment with pelvic radiotherapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age >=18 years to <= 70 years.",
"criterions": [
{
"exact_snippets": "Age >=18 years to <= 70 years.",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 70,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix.",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected gender",
"expected_value": "female"
}
]
},
{
"exact_snippets": "histologically confirmed",
"criterion": "histological confirmation",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
}
]
},
{
"exact_snippets": "primary adenocarcinoma or squamous cell carcinoma",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"adenocarcinoma",
"squamous cell carcinoma"
]
}
]
},
{
"exact_snippets": "of the uterine cervix",
"criterion": "cancer location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "uterine cervix"
}
]
}
]
},
{
"line": "* Stage IIA1, or IB1 disease.",
"criterions": [
{
"exact_snippets": "Stage IIA1, or IB1 disease",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "specific stages",
"expected_value": [
"IIA1",
"IB1"
]
}
]
}
]
},
{
"line": "* Karnofsky performance status >70.",
"criterions": [
{
"exact_snippets": "Karnofsky performance status >70",
"criterion": "Karnofsky performance status",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 70,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Patients who comply with follow-up.",
"criterions": [
{
"exact_snippets": "Patients who comply with follow-up.",
"criterion": "follow-up compliance",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
},
{
"line": "* With written informed consent.",
"criterions": [
{
"exact_snippets": "written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"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 be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "female"
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Age>70",
"criterions": [
{
"exact_snippets": "Age>70",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 70,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* History of lower urinary tract damage or surgery.",
"criterions": [
{
"exact_snippets": "History of lower urinary tract damage",
"criterion": "lower urinary tract damage",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "History of ... surgery",
"criterion": "surgery",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* With abnormal urodynamic study results.",
"criterions": [
{
"exact_snippets": "abnormal urodynamic study results",
"criterion": "urodynamic study results",
"requirements": [
{
"requirement_type": "normality",
"expected_value": "abnormal"
}
]
}
]
},
{
"line": "* Karnofsky performance status <70.",
"criterions": [
{
"exact_snippets": "Karnofsky performance status <70",
"criterion": "Karnofsky performance status",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 70,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Patients who have uncontrolled psychological disorders.",
"criterions": [
{
"exact_snippets": "uncontrolled psychological disorders",
"criterion": "psychological disorders",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
}
]
},
{
"line": "* Unwilling to or unable to comply with protocol.",
"criterions": [
{
"exact_snippets": "Unwilling to or unable to comply with protocol.",
"criterion": "compliance with protocol",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Prior treatment with pelvic radiotherapy",
"criterions": [
{
"exact_snippets": "Prior treatment with pelvic radiotherapy",
"criterion": "pelvic radiotherapy",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}