{
    "info": {
        "nct_id": "NCT06640348",
        "official_title": "Ultrasensitive SERS Platform With Highly Efficient Enrichment of Analyte for Screening and Diagnosis of Epithelial Ovarian Cancer",
        "inclusion_criteria": "1. The subjects understand the trial process, sign the informed consent form, voluntarily participate in the study, and are capable of following the protocol;\n2. Aged 18 to 70 (inclusive):\n\nCancer group: Ovarian cancer patients (50 cases of high-grade serous ovarian cancer, 15 cases of low-grade serous ovarian cancer, 20 cases of endometrioid ovarian cancer, 20 cases of clear cell carcinoma) i. All ovarian cancer patients are initial treatment patients with complete clinical data; ii. Patients have an ECOG performance status score of 0-3 and a life expectancy of more than 6 months; iii. Subjects consent to blood sample collection for SERS analysis (provided free of charge); iv. Good organ function.\n\nNormal control group: (20 cases) i. Normal control subjects are patients undergoing surgery for benign diseases; ii. Patients have complete clinical data; iii. Subjects have not undergone any radical treatment for the benign lesion prior to blood collection.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, gastrointestinal diseases that may interfere with drug absorption and metabolism, mental illnesses affecting the patient's ability to sign the informed consent form, a history of severe cardiovascular disease, infectious diseases (such as syphilis, AIDS, active hepatitis C, or active hepatitis B), infectious conditions (such as abscesses), or active rheumatic diseases, etc.;\n2. A history of blood transfusion within 4 weeks prior to the study;\n3. Pregnant, postpartum, or breastfeeding patients, or patients planning to become pregnant during the study treatment;\n4. Patients with a history of other tumors;\n5. The investigator deems the subject unsuitable for participation in this clinical study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. The subjects understand the trial process, sign the informed consent form, voluntarily participate in the study, and are capable of following the protocol;",
            "criterions": [
                {
                    "exact_snippets": "subjects understand the trial process",
                    "criterion": "understanding of trial process",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily participate in the study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "capable of following the protocol",
                    "criterion": "capability to follow protocol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Aged 18 to 70 (inclusive):",
            "criterions": [
                {
                    "exact_snippets": "Aged 18 to 70 (inclusive)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cancer group: Ovarian cancer patients (50 cases of high-grade serous ovarian cancer, 15 cases of low-grade serous ovarian cancer, 20 cases of endometrioid ovarian cancer, 20 cases of clear cell carcinoma) i. All ovarian cancer patients are initial treatment patients with complete clinical data; ii. Patients have an ECOG performance status score of 0-3 and a life expectancy of more than 6 months; iii. Subjects consent to blood sample collection for SERS analysis (provided free of charge); iv. Good organ function.",
            "criterions": [
                {
                    "exact_snippets": "Ovarian cancer patients",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "ovarian cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "high-grade serous ovarian cancer",
                    "criterion": "cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "high-grade serous"
                        }
                    ]
                },
                {
                    "exact_snippets": "low-grade serous ovarian cancer",
                    "criterion": "cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "low-grade serous"
                        }
                    ]
                },
                {
                    "exact_snippets": "endometrioid ovarian cancer",
                    "criterion": "cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "endometrioid"
                        }
                    ]
                },
                {
                    "exact_snippets": "clear cell carcinoma",
                    "criterion": "cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "clear cell carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "initial treatment patients",
                    "criterion": "treatment status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "initial treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "complete clinical data",
                    "criterion": "clinical data",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG performance status score of 0-3",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy of more than 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "consent to blood sample collection for SERS analysis",
                    "criterion": "consent for blood sample collection",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Good organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Normal control group: (20 cases) i. Normal control subjects are patients undergoing surgery for benign diseases; ii. Patients have complete clinical data; iii. Subjects have not undergone any radical treatment for the benign lesion prior to blood collection.",
            "criterions": [
                {
                    "exact_snippets": "Normal control subjects are patients undergoing surgery for benign diseases",
                    "criterion": "surgery for benign diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients have complete clinical data",
                    "criterion": "complete clinical data",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects have not undergone any radical treatment for the benign lesion prior to blood collection",
                    "criterion": "radical treatment for the benign lesion prior to blood collection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "expected_value",
                            "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": "1. Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, gastrointestinal diseases that may interfere with drug absorption and metabolism, mental illnesses affecting the patient's ability to sign the informed consent form, a history of severe cardiovascular disease, infectious diseases (such as syphilis, AIDS, active hepatitis C, or active hepatitis B), infectious conditions (such as abscesses), or active rheumatic diseases, etc.;",
            "criterions": [
                {
                    "exact_snippets": "Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting",
                    "criterion": "nausea and vomiting",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "uncontrollable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled diseases, including but not limited to: ... gastrointestinal diseases that may interfere with drug absorption and metabolism",
                    "criterion": "gastrointestinal diseases",
                    "requirements": [
                        {
                            "requirement_type": "interference with drug absorption and metabolism",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled diseases, including but not limited to: ... mental illnesses affecting the patient's ability to sign the informed consent form",
                    "criterion": "mental illnesses",
                    "requirements": [
                        {
                            "requirement_type": "affecting ability to sign informed consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled diseases, including but not limited to: ... a history of severe cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled diseases, including but not limited to: ... infectious diseases (such as syphilis, AIDS, active hepatitis C, or active hepatitis B)",
                    "criterion": "infectious diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "syphilis",
                                "AIDS",
                                "active hepatitis C",
                                "active hepatitis B"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled diseases, including but not limited to: ... infectious conditions (such as abscesses)",
                    "criterion": "infectious conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "abscesses"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled diseases, including but not limited to: ... active rheumatic diseases",
                    "criterion": "rheumatic diseases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. A history of blood transfusion within 4 weeks prior to the study;",
            "criterions": [
                {
                    "exact_snippets": "A history of blood transfusion within 4 weeks prior to the study",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pregnant, postpartum, or breastfeeding patients, or patients planning to become pregnant during the study treatment;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "postpartum",
                    "criterion": "postpartum status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postpartum"
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "breastfeeding"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients planning to become pregnant during the study treatment",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "planning to become pregnant during the study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with a history of other tumors;",
            "criterions": [
                {
                    "exact_snippets": "history of other tumors",
                    "criterion": "other tumors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The investigator deems the subject unsuitable for participation in this clinical study.",
            "criterions": [
                {
                    "exact_snippets": "The investigator deems the subject unsuitable for participation",
                    "criterion": "suitability for participation",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "suitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}