{
    "info": {
        "nct_id": "NCT04675320",
        "official_title": "Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors",
        "inclusion_criteria": "1. Patient over 18 years\n2. Patient treated for epithelial ovarian cancer\n3. Eligible for anti-PARP therapy and in one of the 2 cohorts below:\n\n   * Cohort 1: Maintenance treatment of adult patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) with or without BRCA1/2 mutation, who have had a partial or complete response to first-line platinum-based chemotherapy.\n   * 2nd cohort: single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.\n4. Patient having signed the informed consent form.\n5. Patient fit and able to comply with the protocol for the duration of the study, including visits, scheduled sampling and follow-up.\n6. Patient affiliated to the social security system.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Non-epithelial tumour of the ovary\n2. Patient unable to understand, read and/or sign informed consent.\n3. Current or previous use of immunosuppressive medication within 14 days prior to inclusion (except intranasal corticosteroids, systemic corticosteroids in physiological doses not exceeding 10 mg daily of prednisone or its equivalent, corticosteroids used as premedication for hypersensitivity reactions.\n4. Patient participating in other research that may modify the systemic treatment administered in the cohort in which she will be included.\n5. Pregnant or breast-feeding women.\n6. HIV and/or HBV and/or HCV serology positive.\n7. Patient refusal.\n8. Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice).\n9. Inability to undergo medical follow-up for geographical, social or psychological reasons.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient over 18 years",
            "criterions": [
                {
                    "exact_snippets": "Patient over 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient treated for epithelial ovarian cancer",
            "criterions": [
                {
                    "exact_snippets": "treated for epithelial ovarian cancer",
                    "criterion": "epithelial ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Eligible for anti-PARP therapy and in one of the 2 cohorts below:",
            "criterions": [
                {
                    "exact_snippets": "Eligible for anti-PARP therapy",
                    "criterion": "anti-PARP therapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 1: Maintenance treatment of adult patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) with or without BRCA1/2 mutation, who have had a partial or complete response to first-line platinum-based chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "adult patients",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer",
                    "criterion": "cancer type and stage",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "epithelial ovarian cancer",
                                "fallopian tube cancer",
                                "primary peritoneal cancer"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "FIGO stage III",
                                "FIGO stage IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without BRCA1/2 mutation",
                    "criterion": "BRCA1/2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "with or without"
                        }
                    ]
                },
                {
                    "exact_snippets": "partial or complete response to first-line platinum-based chemotherapy",
                    "criterion": "response to chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response type",
                            "expected_value": [
                                "partial response",
                                "complete response"
                            ]
                        },
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "first-line platinum-based chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2nd cohort: single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "adult patients",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "platinum-sensitive",
                    "criterion": "platinum sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": "platinum-sensitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "epithelial ovarian",
                                "fallopian tube",
                                "peritoneal"
                            ]
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have responded (completely or partially) to platinum-based chemotherapy",
                    "criterion": "response to platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "complete",
                                "partial"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient having signed the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Patient having signed the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient fit and able to comply with the protocol for the duration of the study, including visits, scheduled sampling and follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Patient fit",
                    "criterion": "patient fitness",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to comply with the protocol for the duration of the study",
                    "criterion": "protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including visits, scheduled sampling and follow-up",
                    "criterion": "study procedures",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": [
                                "visits",
                                "scheduled sampling",
                                "follow-up"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient affiliated to the social security system.",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated to the social security system.",
                    "criterion": "social security system affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "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": "1. Non-epithelial tumour of the ovary",
            "criterions": [
                {
                    "exact_snippets": "Non-epithelial tumour of the ovary",
                    "criterion": "ovarian tumour",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-epithelial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient unable to understand, read and/or sign informed consent.",
            "criterions": [
                {
                    "exact_snippets": "unable to understand",
                    "criterion": "understanding ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to ... read",
                    "criterion": "reading ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to ... sign informed consent",
                    "criterion": "ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Current or previous use of immunosuppressive medication within 14 days prior to inclusion (except intranasal corticosteroids, systemic corticosteroids in physiological doses not exceeding 10 mg daily of prednisone or its equivalent, corticosteroids used as premedication for hypersensitivity reactions.",
            "criterions": [
                {
                    "exact_snippets": "Current or previous use of immunosuppressive medication within 14 days prior to inclusion",
                    "criterion": "use of immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days prior to inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "except intranasal corticosteroids",
                    "criterion": "use of intranasal corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic corticosteroids in physiological doses not exceeding 10 mg daily of prednisone or its equivalent",
                    "criterion": "use of systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg daily of prednisone or its equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "corticosteroids used as premedication for hypersensitivity reactions",
                    "criterion": "use of corticosteroids as premedication for hypersensitivity reactions",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient participating in other research that may modify the systemic treatment administered in the cohort in which she will be included.",
            "criterions": [
                {
                    "exact_snippets": "Patient participating in other research",
                    "criterion": "participation in other research",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pregnant or breast-feeding women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. HIV and/or HBV and/or HCV serology positive.",
            "criterions": [
                {
                    "exact_snippets": "HIV ... serology positive",
                    "criterion": "HIV serology",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV ... serology positive",
                    "criterion": "HBV serology",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV serology positive",
                    "criterion": "HCV serology",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patient refusal.",
            "criterions": [
                {
                    "exact_snippets": "Patient refusal",
                    "criterion": "patient consent",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice).",
            "criterions": [
                {
                    "exact_snippets": "Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice)",
                    "criterion": "system of protection for adults",
                    "requirements": [
                        {
                            "requirement_type": "benefiting",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Inability to undergo medical follow-up for geographical, social or psychological reasons.",
            "criterions": [
                {
                    "exact_snippets": "Inability to undergo medical follow-up for geographical ... reasons.",
                    "criterion": "ability to undergo medical follow-up",
                    "requirements": [
                        {
                            "requirement_type": "geographical",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to undergo medical follow-up for ... social ... reasons.",
                    "criterion": "ability to undergo medical follow-up",
                    "requirements": [
                        {
                            "requirement_type": "social",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to undergo medical follow-up for ... psychological reasons.",
                    "criterion": "ability to undergo medical follow-up",
                    "requirements": [
                        {
                            "requirement_type": "psychological",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}