{
    "info": {
        "nct_id": "NCT00368420",
        "official_title": "Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer",
        "inclusion_criteria": "* Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy.\n* Women aged > 18 years\n* Patients who have given their signed and written informed consent to data transmission and -processing\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with non-epithelial tumors as well as borderline tumors\n* Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval\n* Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer\n* Patients with a third recurrence\n* Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy.",
            "criterions": [
                {
                    "exact_snippets": "recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "invasive epithelial ovarian cancer",
                                "fallopian tube cancer",
                                "primary peritoneal cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "any initial stage",
                    "criterion": "initial stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy",
                    "criterion": "tumor-free interval after first-line therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "second relapse who are enrolled after completed platinum-containing re-induction therapy",
                    "criterion": "second relapse after platinum-containing re-induction therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women aged > 18 years",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have given their signed and written informed consent to data transmission and -processing",
            "criterions": [
                {
                    "exact_snippets": "Patients who have given their signed and written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "consent to data transmission and -processing",
                    "criterion": "consent to data transmission and processing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with non-epithelial tumors as well as borderline tumors",
            "criterions": [
                {
                    "exact_snippets": "non-epithelial tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-epithelial"
                        }
                    ]
                },
                {
                    "exact_snippets": "borderline tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "borderline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval",
            "criterions": [
                {
                    "exact_snippets": "Patients who undergo second-look surgery",
                    "criterion": "second-look surgery",
                    "requirements": [
                        {
                            "requirement_type": "undergo",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "completion surgery after end of chemotherapy",
                    "criterion": "completion surgery",
                    "requirements": [
                        {
                            "requirement_type": "undergo",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "completion surgery ... during the interval",
                    "criterion": "completion surgery",
                    "requirements": [
                        {
                            "requirement_type": "undergo",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer",
            "criterions": [
                {
                    "exact_snippets": "patients with second malignancies",
                    "criterion": "second malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated by laparotomy",
                    "criterion": "treatment by laparotomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other neoplasias",
                    "criterion": "other neoplasias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment could interfere with the treatment of relapsed ovarian cancer",
                    "criterion": "treatment interference with relapsed ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "potential interference",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a third recurrence",
            "criterions": [
                {
                    "exact_snippets": "third recurrence",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy",
            "criterions": [
                {
                    "exact_snippets": "platinum-refractory tumor",
                    "criterion": "platinum-refractory tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progression during chemotherapy",
                    "criterion": "tumor progression during chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrence within 6 months after end of former platinum-containing therapy",
                    "criterion": "tumor recurrence after platinum-containing therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}