{
    "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": [
        {
            "line": "* Non-metastatic prostate adenocarcinoma confirmed by histopathology after taking core needle biopsy",
            "criterions": [
                {
                    "exact_snippets": "Non-metastatic prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by histopathology",
                    "criterion": "histopathological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after taking core needle biopsy",
                    "criterion": "core needle biopsy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "core needle biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Regular visits, treatment and laboratory tests were conducted in the past",
            "criterions": [
                {
                    "exact_snippets": "Regular visits",
                    "criterion": "regular visits",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory tests",
                    "criterion": "laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of diagnosis"
                        }
                    ]
                },
                {
                    "exact_snippets": "without staining FFPE",
                    "criterion": "staining FFPE",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "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",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "relevance",
                            "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 MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 50 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 50 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "FFPE does not meet the screening requirements of study samples",
                    "criterion": "FFPE",
                    "requirements": [
                        {
                            "requirement_type": "screening requirements",
                            "expected_value": "does not meet"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Relevent clinical parameters of the patients are not available",
            "criterions": [
                {
                    "exact_snippets": "clinical parameters ... are not available",
                    "criterion": "clinical parameters",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment methods are not available",
            "criterions": [
                {
                    "exact_snippets": "Treatment methods are not available",
                    "criterion": "treatment methods",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age of diagnosis < 50 years",
            "criterions": [
                {
                    "exact_snippets": "Age of diagnosis < 50 years",
                    "criterion": "age of diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age of diagnosis > 100 years",
            "criterions": [
                {
                    "exact_snippets": "Age of diagnosis > 100 years",
                    "criterion": "age of diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total tumor length < 2 mm",
            "criterions": [
                {
                    "exact_snippets": "Total tumor length < 2 mm",
                    "criterion": "tumor length",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient died of an accident, homicide or suicide",
            "criterions": [
                {
                    "exact_snippets": "The patient died of an accident",
                    "criterion": "cause of death",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "accident"
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient died of ... homicide",
                    "criterion": "cause of death",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "homicide"
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient died of ... suicide",
                    "criterion": "cause of death",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "suicide"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}