[96a5a0]: / output / allTrials / identified / NCT02765620_identified.json

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{
"info": {
"nct_id": "NCT02765620",
"official_title": "PERCIST Criteria for Response Evaluation of Non-surgical Therapy in Patients With Solid Tumors:Prospective Multicenter Study",
"inclusion_criteria": "* Age 30-80 years old ( might differ based on certain cancer type)\n* Newly diagnosis of solid tumor proved by imaging\n* Pathology proved to be primary solid tumor\n* First PET/CT scan was performed before any kinds of anti-tumor treatment including surgery\n* No other anti-tumor treatments except for that required during the trial\n* Written and informed consent with signature before the study\n* Complete medical history and clinical record (including physical examination, electrocardiogram, hematology, biochemistry, tumor pathology etc)\n* Follow-up of PSF and OS over a year\nHealthy volunteers allowed\nMust have minimum age of 30 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Pregnancy, lactation, and impaired renal or liver function\n* Receive additional anti-tumor treatments (including surgery) other than that required during the trial\n* Poorly controlled diabetes\n* Poor compliance\n* Failed to perform scans\n* Contrary to the standard operating procedures\n* Without a definite pathologic diagnosis or follow-up results\n* Not suitable for clinical trials (for example with mental illness)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age 30-80 years old ( might differ based on certain cancer type)",
"criterions": [
{
"exact_snippets": "Age 30-80 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 30,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Newly diagnosis of solid tumor proved by imaging",
"criterions": [
{
"exact_snippets": "Newly diagnosis of solid tumor",
"criterion": "solid tumor",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "newly"
}
]
},
{
"exact_snippets": "proved by imaging",
"criterion": "imaging proof",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Pathology proved to be primary solid tumor",
"criterions": [
{
"exact_snippets": "Pathology proved to be primary solid tumor",
"criterion": "primary solid tumor",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
}
]
}
]
},
{
"line": "* First PET/CT scan was performed before any kinds of anti-tumor treatment including surgery",
"criterions": [
{
"exact_snippets": "First PET/CT scan was performed before any kinds of anti-tumor treatment including surgery",
"criterion": "PET/CT scan",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "before any kinds of anti-tumor treatment including surgery"
}
]
}
]
},
{
"line": "* No other anti-tumor treatments except for that required during the trial",
"criterions": [
{
"exact_snippets": "No other anti-tumor treatments",
"criterion": "anti-tumor treatments",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Written and informed consent with signature before the study",
"criterions": [
{
"exact_snippets": "Written and informed consent with signature",
"criterion": "consent",
"requirements": [
{
"requirement_type": "type",
"expected_value": "written and informed"
},
{
"requirement_type": "signature",
"expected_value": true
}
]
}
]
},
{
"line": "* Complete medical history and clinical record (including physical examination, electrocardiogram, hematology, biochemistry, tumor pathology etc)",
"criterions": [
{
"exact_snippets": "Complete medical history",
"criterion": "medical history",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": true
}
]
},
{
"exact_snippets": "clinical record",
"criterion": "clinical record",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": true
}
]
},
{
"exact_snippets": "physical examination",
"criterion": "physical examination",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "electrocardiogram",
"criterion": "electrocardiogram",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hematology",
"criterion": "hematology",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "biochemistry",
"criterion": "biochemistry",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "tumor pathology",
"criterion": "tumor pathology",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Follow-up of PSF and OS over a year",
"criterions": [
{
"exact_snippets": "Follow-up of PSF",
"criterion": "PSF follow-up",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "year"
}
}
]
},
{
"exact_snippets": "Follow-up of ... OS",
"criterion": "OS follow-up",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "year"
}
}
]
}
]
},
{
"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 30 Years",
"criterions": [
{
"exact_snippets": "minimum age of 30 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Pregnancy, lactation, and impaired renal or liver function",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactation",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "impaired renal ... function",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "impairment",
"expected_value": false
}
]
},
{
"exact_snippets": "impaired ... liver function",
"criterion": "liver function",
"requirements": [
{
"requirement_type": "impairment",
"expected_value": false
}
]
}
]
},
{
"line": "* Receive additional anti-tumor treatments (including surgery) other than that required during the trial",
"criterions": [
{
"exact_snippets": "Receive additional anti-tumor treatments (including surgery)",
"criterion": "additional anti-tumor treatments",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Poorly controlled diabetes",
"criterions": [
{
"exact_snippets": "Poorly controlled diabetes",
"criterion": "diabetes",
"requirements": [
{
"requirement_type": "control",
"expected_value": "poorly controlled"
}
]
}
]
},
{
"line": "* Poor compliance",
"criterions": [
{
"exact_snippets": "Poor compliance",
"criterion": "compliance",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "poor"
}
]
}
]
},
{
"line": "* Failed to perform scans",
"criterions": [
{
"exact_snippets": "Failed to perform scans",
"criterion": "scans",
"requirements": [
{
"requirement_type": "performance",
"expected_value": false
}
]
}
]
},
{
"line": "* Without a definite pathologic diagnosis or follow-up results",
"criterions": [
{
"exact_snippets": "Without a definite pathologic diagnosis",
"criterion": "pathologic diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Without ... follow-up results",
"criterion": "follow-up results",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Not suitable for clinical trials (for example with mental illness)",
"criterions": [
{
"exact_snippets": "Not suitable for clinical trials (for example with mental illness)",
"criterion": "suitability for clinical trials",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": false
}
]
},
{
"exact_snippets": "mental illness",
"criterion": "mental illness",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* Contrary to the standard operating procedures",
"criterions": []
}
],
"failed_miscellaneous": []
}