{
    "info": {
        "nct_id": "NCT05574673",
        "official_title": "Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study",
        "inclusion_criteria": "Must be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Patients are eligible to be included in the study, if all the following inclusion criteria are met:\n\n* Patients with newly diagnosed histologically confirmed epithelial ovarian cancer:\n\n  * FIGO stage I-II with a known BRCA1/2 mutation (germline/gBRCA or somatic/tBRCA)\n  * FIGO stage III-IV of any histology\n* Women aged ≥18 years of age at the time of diagnosis\n* Patients intended for platinum-based chemotherapy treatment\n* Patients capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n* Patients consent to provide archival tumor tissue sample\n\nPatients are ineligible to be included in the study, if any of the exclusion criteria are met:\n\n* Non-epithelial ovarian cancer, borderline tumors, or mucinous histology\n* Patients with FIGO stage I-II, BRCAwt ovarian cancer"
    },
    "inclusion_lines": [
        {
            "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 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": [],
    "miscellaneous_lines": [
        {
            "line": "* Patients with newly diagnosed histologically confirmed epithelial ovarian cancer:",
            "criterions": [
                {
                    "exact_snippets": "newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "epithelial ovarian cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "epithelial ovarian cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FIGO stage I-II with a known BRCA1/2 mutation (germline/gBRCA or somatic/tBRCA)",
            "criterions": [
                {
                    "exact_snippets": "FIGO stage I-II",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "known BRCA1/2 mutation (germline/gBRCA or somatic/tBRCA)",
                    "criterion": "BRCA1/2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "germline/gBRCA",
                                "somatic/tBRCA"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FIGO stage III-IV of any histology",
            "criterions": [
                {
                    "exact_snippets": "FIGO stage III-IV",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any histology",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women aged ≥18 years of age at the time of diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients intended for platinum-based chemotherapy treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients intended for platinum-based chemotherapy treatment",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "platinum-based"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol",
            "criterions": [
                {
                    "exact_snippets": "Patients capable of giving signed informed consent",
                    "criterion": "informed consent capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol",
                    "criterion": "compliance with ICF and protocol",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients consent to provide archival tumor tissue sample",
            "criterions": [
                {
                    "exact_snippets": "consent to provide archival tumor tissue sample",
                    "criterion": "archival tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients are ineligible to be included in the study, if any of the exclusion criteria are met:",
            "criterions": [
                {
                    "exact_snippets": "Patients are ineligible to be included in the study, if any of the exclusion criteria are met",
                    "criterion": "exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-epithelial ovarian cancer, borderline tumors, or mucinous histology",
            "criterions": [
                {
                    "exact_snippets": "Non-epithelial ovarian cancer",
                    "criterion": "ovarian cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-epithelial"
                        }
                    ]
                },
                {
                    "exact_snippets": "borderline tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "borderline"
                        }
                    ]
                },
                {
                    "exact_snippets": "mucinous histology",
                    "criterion": "histology type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "mucinous"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with FIGO stage I-II, BRCAwt ovarian cancer",
            "criterions": [
                {
                    "exact_snippets": "FIGO stage I-II",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "BRCAwt ovarian cancer",
                    "criterion": "BRCA status",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "wild-type"
                        }
                    ]
                },
                {
                    "exact_snippets": "BRCAwt ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Patients are eligible to be included in the study, if all the following inclusion criteria are met:",
            "criterions": []
        }
    ]
}