{
    "info": {
        "nct_id": "NCT02327572",
        "official_title": "Age-related Changes in the Immune System and Their Impact on Elderly Breast Cancer",
        "inclusion_criteria": "* o Patients newly diagnosed with breast cancer who will undergo surgery and gave written informed consent\n\n  * Group 1 : 30 patients aged 70+ Group 2 : 15 patients aged 55-65 (post-menopausal) Group 3 : 15 patients aged 35-45 (pre-menopausal)\n  * Tumor selection : grade II/III invasive tumor, any histological type, ER-positive, HER2-negative\n  * Tumor size ≥1.5 cm (clinical assessment: mammoechography and/or clinical examination)\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 35 Years",
        "exclusion_criteria": "-",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* o Patients newly diagnosed with breast cancer who will undergo surgery and gave written informed consent",
            "criterions": [
                {
                    "exact_snippets": "newly diagnosed with breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "will undergo surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "future procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gave written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "written",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Group 1 : 30 patients aged 70+ Group 2 : 15 patients aged 55-65 (post-menopausal) Group 3 : 15 patients aged 35-45 (pre-menopausal)",
            "criterions": [
                {
                    "exact_snippets": "Group 1 : 30 patients aged 70+",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Group 2 : 15 patients aged 55-65 (post-menopausal)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 55,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Group 2 : 15 patients aged 55-65 (post-menopausal)",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Group 3 : 15 patients aged 35-45 (pre-menopausal)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 35,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 45,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Group 3 : 15 patients aged 35-45 (pre-menopausal)",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pre-menopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor selection : grade II/III invasive tumor, any histological type, ER-positive, HER2-negative",
            "criterions": [
                {
                    "exact_snippets": "grade II/III invasive tumor",
                    "criterion": "tumor grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "any histological type",
                    "criterion": "tumor histological type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "ER-positive",
                    "criterion": "ER status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor size ≥1.5 cm (clinical assessment: mammoechography and/or clinical examination)",
            "criterions": [
                {
                    "exact_snippets": "Tumor size ≥1.5 cm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 35 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 35 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 35,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "-",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}