{
    "info": {
        "nct_id": "NCT05529862",
        "official_title": "Trans-RosaLEE Study: a Biomarker-directed, Translational Study of High-throughput Molecular Profiling of HR+/HER2- Metastatic Breast Cancer Treated With Endocrine Therapy and Ribociclib.",
        "inclusion_criteria": "1. Patients included in the RosaLEE study.\n2. Patients having read and signed the ICF relative to Trans-RosaLEE.\n3. Tumour material: primary and/or metastatic tumour sample, either available as frozen and collected within 3 months before V0, or newly collected before ribociclib + ET treatment initiation.\n\n   Brain metastases and non-osteolytic bone metastases will be considered as non-collectable/biopsable.\n4. Patient affiliated to the national \"Social Security\" regimen or beneficiary of this regimen.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Not enrolled in RosaLEE.\n2. Brain metastasis and non-osteolytic bone metastases as only metastatic sites, if no available frozen tumour sample already collected within 3 months before V0.\n3. Tumour material not collected before ribociclib + ET initiation.\n4. Person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to give their consent.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients included in the RosaLEE study.",
            "criterions": [
                {
                    "exact_snippets": "Patients included in the RosaLEE study",
                    "criterion": "RosaLEE study inclusion",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients having read and signed the ICF relative to Trans-RosaLEE.",
            "criterions": [
                {
                    "exact_snippets": "Patients having read and signed the ICF",
                    "criterion": "informed consent form (ICF)",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Tumour material: primary and/or metastatic tumour sample, either available as frozen and collected within 3 months before V0, or newly collected before ribociclib + ET treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Tumour material: primary and/or metastatic tumour sample",
                    "criterion": "tumour material",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "primary",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "either available as frozen",
                    "criterion": "tumour material",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "state",
                            "expected_value": "frozen"
                        }
                    ]
                },
                {
                    "exact_snippets": "collected within 3 months before V0",
                    "criterion": "tumour material",
                    "requirements": [
                        {
                            "requirement_type": "collection time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "newly collected before ribociclib + ET treatment initiation",
                    "criterion": "tumour material",
                    "requirements": [
                        {
                            "requirement_type": "collection time",
                            "expected_value": "before ribociclib + ET treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Brain metastases and non-osteolytic bone metastases will be considered as non-collectable/biopsable.",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "collectability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "biopsability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-osteolytic bone metastases",
                    "criterion": "non-osteolytic bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "collectability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "biopsability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient affiliated to the national \"Social Security\" regimen or beneficiary of this regimen.",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated to the national \"Social Security\" regimen",
                    "criterion": "affiliation to national \"Social Security\" regimen",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "beneficiary of this regimen",
                    "criterion": "beneficiary of national \"Social Security\" regimen",
                    "requirements": [
                        {
                            "requirement_type": "beneficiary status",
                            "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. Not enrolled in RosaLEE.",
            "criterions": [
                {
                    "exact_snippets": "Not enrolled in RosaLEE.",
                    "criterion": "enrollment in RosaLEE",
                    "requirements": [
                        {
                            "requirement_type": "enrollment status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Brain metastasis and non-osteolytic bone metastases as only metastatic sites, if no available frozen tumour sample already collected within 3 months before V0.",
            "criterions": [
                {
                    "exact_snippets": "Brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-osteolytic bone metastases",
                    "criterion": "non-osteolytic bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no available frozen tumour sample",
                    "criterion": "frozen tumour sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "collected within 3 months before V0",
                    "criterion": "frozen tumour sample collection time",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Tumour material not collected before ribociclib + ET initiation.",
            "criterions": [
                {
                    "exact_snippets": "Tumour material not collected before ribociclib + ET initiation.",
                    "criterion": "tumour material collection",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "not before ribociclib + ET initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to give their consent.",
            "criterions": [
                {
                    "exact_snippets": "Person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice)",
                    "criterion": "legal protection measure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to give their consent",
                    "criterion": "ability to give consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}