{
    "info": {
        "nct_id": "NCT05049031",
        "official_title": "Study of the Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk After Initial Treatment in Patients With Non-metastatic Breast Cancer",
        "inclusion_criteria": "* Adult patients who had T1-T3, N0-N2, M0 breast cancer\n* Patients referred to the Menopause center in the context of their breast cancer who were included in the original study evaluating the bone impact of hormone therapy carried out between 2010 \"Bone and cardiovascular impact of adjuvant hormone therapy for cancer non-metastatic breast \"\n* Patient who has given her consent for the study (written or verbal) after clear and fair information\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Metastatic breast tumor\n* Absence of adjuvant hormone therapy for patients whose tumor did not express hormone receptors\n* Patients who have died since the last assessment\n* Protected adult patient (guardianship, curatorship, safeguard of justice)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adult patients who had T1-T3, N0-N2, M0 breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Adult patients",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "T1-T3",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0-N2",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients referred to the Menopause center in the context of their breast cancer who were included in the original study evaluating the bone impact of hormone therapy carried out between 2010 \"Bone and cardiovascular impact of adjuvant hormone therapy for cancer non-metastatic breast \"",
            "criterions": [
                {
                    "exact_snippets": "Patients referred to the Menopause center",
                    "criterion": "referral to Menopause center",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the context of their breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "context",
                            "expected_value": "Menopause center referral"
                        }
                    ]
                },
                {
                    "exact_snippets": "included in the original study evaluating the bone impact of hormone therapy",
                    "criterion": "inclusion in original study",
                    "requirements": [
                        {
                            "requirement_type": "study focus",
                            "expected_value": "bone impact of hormone therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "carried out between 2010",
                    "criterion": "study period",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "2010"
                        }
                    ]
                },
                {
                    "exact_snippets": "Bone and cardiovascular impact of adjuvant hormone therapy for cancer non-metastatic breast",
                    "criterion": "study focus",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": [
                                "bone",
                                "cardiovascular"
                            ]
                        },
                        {
                            "requirement_type": "therapy type",
                            "expected_value": "adjuvant hormone therapy"
                        },
                        {
                            "requirement_type": "cancer type",
                            "expected_value": "non-metastatic breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who has given her consent for the study (written or verbal) after clear and fair information",
            "criterions": [
                {
                    "exact_snippets": "Patient who has given her consent for the study (written or verbal)",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "written",
                                "verbal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Metastatic breast tumor",
            "criterions": [
                {
                    "exact_snippets": "Metastatic breast tumor",
                    "criterion": "breast tumor",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have died since the last assessment",
            "criterions": [
                {
                    "exact_snippets": "Patients who have died since the last assessment",
                    "criterion": "patient status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "deceased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Protected adult patient (guardianship, curatorship, safeguard of justice)",
            "criterions": [
                {
                    "exact_snippets": "Protected adult patient (guardianship, curatorship, safeguard of justice)",
                    "criterion": "protected adult status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "guardianship",
                                "curatorship",
                                "safeguard of justice"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Absence of adjuvant hormone therapy for patients whose tumor did not express hormone receptors",
            "criterions": [
                {
                    "exact_snippets": "absence of adjuvant hormone therapy",
                    "criterion": "adjuvant hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor did not express hormone receptors",
                    "criterion": "hormone receptor expression in tumor",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}