{
"info": {
"nct_id": "NCT05248282",
"official_title": "A Single-Center, Retrospective, Blinded Validation Study to Investigate the Prognostic Value of the Prostatype Test System (PrTS) in Prostate Cancer Patients in China",
"inclusion_criteria": "* Non-metastatic prostate adenocarcinoma confirmed by histopathology after taking core needle biopsy\n* Regular visits, treatment and laboratory tests were conducted in the past\n* There is biopsy materials at the time of diagnosis (without staining FFPE)\n* The total area of tumor tissue shall be 25-30 mm2, and the proportion of tumor cells after tumor cell enrichment is at least 50%\n* Complete records of relevant clinical follow-up information\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 50 Years\nMust have maximum age of 100 Years",
"exclusion_criteria": "* Biopsy tissue is not available, or FFPE does not meet the screening requirements of study samples\n* Relevent clinical parameters of the patients are not available\n* Treatment methods are not available\n* Age of diagnosis < 50 years\n* Age of diagnosis > 100 years\n* Total tumor length < 2 mm\n* The patient died of an accident, homicide or suicide",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Non-metastatic prostate adenocarcinoma confirmed by histopathology after taking core needle biopsy",
"criterions": [
{
"exact_snippets": "Non-metastatic prostate adenocarcinoma",
"criterion": "prostate adenocarcinoma",
"requirement": {
"requirement_type": "metastasis",
"expected_value": false
}
},
{
"exact_snippets": "confirmed by histopathology",
"criterion": "histopathological confirmation",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "after taking core needle biopsy",
"criterion": "core needle biopsy",
"requirement": {
"requirement_type": "procedure",
"expected_value": "core needle biopsy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Non-metastatic prostate adenocarcinoma",
"criterion": "prostate adenocarcinoma",
"requirement": {
"requirement_type": "metastasis",
"expected_value": false
}
},
{
"exact_snippets": "confirmed by histopathology",
"criterion": "histopathological confirmation",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "after taking core needle biopsy",
"criterion": "core needle biopsy",
"requirement": {
"requirement_type": "procedure",
"expected_value": "core needle biopsy"
}
}
]
}
},
{
"identified_line": {
"line": "* Regular visits, treatment and laboratory tests were conducted in the past",
"criterions": [
{
"exact_snippets": "Regular visits",
"criterion": "regular visits",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "treatment",
"criterion": "treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "laboratory tests",
"criterion": "laboratory tests",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Regular visits",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "treatment",
"criterion": "treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "laboratory tests",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
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"line": "* There is biopsy materials at the time of diagnosis (without staining FFPE)",
"criterions": [
{
"exact_snippets": "biopsy materials at the time of diagnosis",
"criterion": "biopsy materials",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "biopsy materials at the time of diagnosis",
"criterion": "biopsy materials",
"requirement": {
"requirement_type": "timing",
"expected_value": "at the time of diagnosis"
}
},
{
"exact_snippets": "without staining FFPE",
"criterion": "staining FFPE",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "biopsy materials at the time of diagnosis",
"criterion": "biopsy materials",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "biopsy materials at the time of diagnosis",
"criterion": "biopsy materials",
"requirement": {
"requirement_type": "timing",
"expected_value": "at the time of diagnosis"
}
}
]
},
{
"exact_snippets": "without staining FFPE",
"criterion": "staining FFPE",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* The total area of tumor tissue shall be 25-30 mm2, and the proportion of tumor cells after tumor cell enrichment is at least 50%",
"criterions": [
{
"exact_snippets": "total area of tumor tissue shall be 25-30 mm2",
"criterion": "tumor tissue area",
"requirement": {
"requirement_type": "size",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 25,
"unit": "mm2"
},
{
"operator": "<=",
"value": 30,
"unit": "mm2"
}
]
}
}
},
{
"exact_snippets": "proportion of tumor cells after tumor cell enrichment is at least 50%",
"criterion": "proportion of tumor cells",
"requirement": {
"requirement_type": "percentage",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "total area of tumor tissue shall be 25-30 mm2",
"criterion": "tumor tissue area",
"requirement": {
"requirement_type": "size",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 25,
"unit": "mm2"
},
{
"operator": "<=",
"value": 30,
"unit": "mm2"
}
]
}
}
},
{
"exact_snippets": "proportion of tumor cells after tumor cell enrichment is at least 50%",
"criterion": "proportion of tumor cells",
"requirement": {
"requirement_type": "percentage",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Complete records of relevant clinical follow-up information",
"criterions": [
{
"exact_snippets": "Complete records of relevant clinical follow-up information",
"criterion": "clinical follow-up information",
"requirement": {
"requirement_type": "completeness",
"expected_value": true
}
},
{
"exact_snippets": "Complete records of relevant clinical follow-up information",
"criterion": "clinical follow-up information",
"requirement": {
"requirement_type": "relevance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Complete records of relevant clinical follow-up information",
"criterion": "clinical follow-up information",
"requirement": {
"requirement_type": "completeness",
"expected_value": true
}
},
{
"exact_snippets": "Complete records of relevant clinical follow-up information",
"criterion": "clinical follow-up information",
"requirement": {
"requirement_type": "relevance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 50 Years",
"criterions": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 100 Years",
"criterions": [
{
"exact_snippets": "maximum age of 100 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 100,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 100 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 100,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Biopsy tissue is not available, or FFPE does not meet the screening requirements of study samples",
"criterions": [
{
"exact_snippets": "Biopsy tissue is not available",
"criterion": "biopsy tissue",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
},
{
"exact_snippets": "FFPE does not meet the screening requirements of study samples",
"criterion": "FFPE",
"requirement": {
"requirement_type": "screening requirements",
"expected_value": "does not meet"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Biopsy tissue is not available",
"criterion": "biopsy tissue",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
},
{
"exact_snippets": "FFPE does not meet the screening requirements of study samples",
"criterion": "FFPE",
"requirement": {
"requirement_type": "screening requirements",
"expected_value": "does not meet"
}
}
]
}
},
{
"identified_line": {
"line": "* Relevent clinical parameters of the patients are not available",
"criterions": [
{
"exact_snippets": "clinical parameters ... are not available",
"criterion": "clinical parameters",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
},
"logical_structure": {
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"criterion": "clinical parameters",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Treatment methods are not available",
"criterions": [
{
"exact_snippets": "Treatment methods are not available",
"criterion": "treatment methods",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "Treatment methods are not available",
"criterion": "treatment methods",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Age of diagnosis < 50 years",
"criterions": [
{
"exact_snippets": "Age of diagnosis < 50 years",
"criterion": "age of diagnosis",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age of diagnosis < 50 years",
"criterion": "age of diagnosis",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Age of diagnosis > 100 years",
"criterions": [
{
"exact_snippets": "Age of diagnosis > 100 years",
"criterion": "age of diagnosis",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": ">",
"value": 100,
"unit": "years"
}
}
}
]
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"exact_snippets": "Age of diagnosis > 100 years",
"criterion": "age of diagnosis",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": ">",
"value": 100,
"unit": "years"
}
}
}
}
},
{
"identified_line": {
"line": "* Total tumor length < 2 mm",
"criterions": [
{
"exact_snippets": "Total tumor length < 2 mm",
"criterion": "tumor length",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "mm"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Total tumor length < 2 mm",
"criterion": "tumor length",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "mm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* The patient died of an accident, homicide or suicide",
"criterions": [
{
"exact_snippets": "The patient died of an accident",
"criterion": "cause of death",
"requirement": {
"requirement_type": "type",
"expected_value": "accident"
}
},
{
"exact_snippets": "The patient died of ... homicide",
"criterion": "cause of death",
"requirement": {
"requirement_type": "type",
"expected_value": "homicide"
}
},
{
"exact_snippets": "The patient died of ... suicide",
"criterion": "cause of death",
"requirement": {
"requirement_type": "type",
"expected_value": "suicide"
}
}
]
},
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"exact_snippets": "The patient died of an accident",
"criterion": "cause of death",
"requirement": {
"requirement_type": "type",
"expected_value": "accident"
}
},
{
"exact_snippets": "The patient died of ... homicide",
"criterion": "cause of death",
"requirement": {
"requirement_type": "type",
"expected_value": "homicide"
}
},
{
"exact_snippets": "The patient died of ... suicide",
"criterion": "cause of death",
"requirement": {
"requirement_type": "type",
"expected_value": "suicide"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}