{
    "info": {
        "nct_id": "NCT02473120",
        "official_title": "Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer",
        "inclusion_criteria": "* Woman aged superior to 18 years old\n* Inform consent signed\n* Metastatic breast cancer or loco-regionnaly advanced breast cancer\n* Inoperable\n* With an indication to treat with aromatase inhibitor\n* Treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease\n* Without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution\n* Treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* No inform consent signed\n* Patient under guardianship, curatorship\n* Psychosocial disorder\n* No affiliated or beneficiary of a social benefit system",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Woman aged superior to 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Woman",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged superior to 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inform consent signed",
            "criterions": [
                {
                    "exact_snippets": "Inform consent signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic breast cancer or loco-regionnaly advanced breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Metastatic breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "loco-regionnaly advanced breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "loco-regionally advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inoperable",
            "criterions": [
                {
                    "exact_snippets": "Inoperable",
                    "criterion": "operability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "inoperable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With an indication to treat with aromatase inhibitor",
            "criterions": [
                {
                    "exact_snippets": "indication to treat with aromatase inhibitor",
                    "criterion": "indication for aromatase inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease",
            "criterions": [
                {
                    "exact_snippets": "Treatment with aromatase inhibitors",
                    "criterion": "aromatase inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "initiation",
                            "expected_value": "at inclusion or at least 6 months before inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "stable disease",
                    "criterion": "disease stability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution",
            "criterions": [
                {
                    "exact_snippets": "Without precedent treatment",
                    "criterion": "precedent treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment",
                    "criterion": "adjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "chemotherapy",
                                "tamoxifen",
                                "faslodex",
                                "aromatase inhibitors"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution",
                    "criterion": "time frame between last treatment with aromatase inhibitors and metastatic evolution",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)",
            "criterions": [
                {
                    "exact_snippets": "Treatment by aromatase inhibitors",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "aromatase inhibitors"
                        }
                    ]
                },
                {
                    "exact_snippets": "in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)",
                    "criterion": "combination treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "trastuzumab",
                                "pertuzumab",
                                "bevacizumab",
                                "everolimus"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* No inform consent signed",
            "criterions": [
                {
                    "exact_snippets": "No inform consent signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient under guardianship, curatorship",
            "criterions": [
                {
                    "exact_snippets": "Patient under guardianship",
                    "criterion": "guardianship",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient ... curatorship",
                    "criterion": "curatorship",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychosocial disorder",
            "criterions": [
                {
                    "exact_snippets": "Psychosocial disorder",
                    "criterion": "psychosocial disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No affiliated or beneficiary of a social benefit system",
            "criterions": [
                {
                    "exact_snippets": "No affiliated or beneficiary of a social benefit system",
                    "criterion": "affiliation with social benefit system",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No affiliated or beneficiary of a social benefit system",
                    "criterion": "beneficiary of a social benefit system",
                    "requirements": [
                        {
                            "requirement_type": "beneficiary status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}