{
    "info": {
        "nct_id": "NCT02266420",
        "official_title": "Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm.",
        "inclusion_criteria": "1. Woman with age ≥ 18 years.\n2. Patient who completed surgery for his breast cancer and for which definitive histo-pathological analysis of surgical specimen is available.\n3. Invasive breast carcinoma pN0 or pN(i+) with histological tumor size ≤ 10 mm (pT1a/b subgroup) or invasive breast carcinoma with histological tumor size > 10 mm and ≤ 30 mm (pT1c T2 ≤ 30 mm control group).\n4. Patient with HER2-negative breast carcinoma: immuno-histochemistry (IHC) score = 0, 1+ or 2+ and in situ hybridization (FISH, CISH, or SISH) negative (local laboratory testing).\n5. Patient with ER and PR negative invasive carcinoma (< 1% stained cells by immuno-histochemistry assay) (local laboratory testing).\n6. In case of multifocality, the histological size of the largest tumor must be ≤ 10 mm or ≤ 30 mm according to the inclusion subgroup. All lesions must be ER, PR and HER2-negative.\n7. In case of breast conserving surgery, clear margins are required.\n8. Patient affiliated to a Social Health Insurance in France.\n9. Patient information and written informed consent form signed prior to any study specific procedures.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients with any previous malignancy of the breast or other site, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer totally resected.\n2. Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively).\n3. Inoperable breast invasive carcinoma.\n4. Synchronous bilateral breast cancer.\n5. Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery).\n6. Pregnant or breast-feeding women.\n7. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n8. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Woman with age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Woman",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient who completed surgery for his breast cancer and for which definitive histo-pathological analysis of surgical specimen is available.",
            "criterions": [
                {
                    "exact_snippets": "completed surgery for his breast cancer",
                    "criterion": "surgery for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "definitive histo-pathological analysis of surgical specimen is available",
                    "criterion": "histo-pathological analysis of surgical specimen",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Invasive breast carcinoma pN0 or pN(i+) with histological tumor size ≤ 10 mm (pT1a/b subgroup) or invasive breast carcinoma with histological tumor size > 10 mm and ≤ 30 mm (pT1c T2 ≤ 30 mm control group).",
            "criterions": [
                {
                    "exact_snippets": "Invasive breast carcinoma",
                    "criterion": "breast carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pN0 or pN(i+)",
                    "criterion": "nodal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "pN0",
                                "pN(i+)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histological tumor size ≤ 10 mm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "histological tumor size > 10 mm and ≤ 30 mm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 10,
                                        "unit": "mm"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "mm"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient with HER2-negative breast carcinoma: immuno-histochemistry (IHC) score = 0, 1+ or 2+ and in situ hybridization (FISH, CISH, or SISH) negative (local laboratory testing).",
            "criterions": [
                {
                    "exact_snippets": "HER2-negative breast carcinoma",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "immuno-histochemistry (IHC) score = 0, 1+ or 2+",
                    "criterion": "IHC score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": [
                                "0",
                                "1+",
                                "2+"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ hybridization (FISH, CISH, or SISH) negative",
                    "criterion": "in situ hybridization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient with ER and PR negative invasive carcinoma (< 1% stained cells by immuno-histochemistry assay) (local laboratory testing).",
            "criterions": [
                {
                    "exact_snippets": "ER and PR negative invasive carcinoma",
                    "criterion": "ER and PR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ER negative",
                                "PR negative"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "< 1% stained cells by immuno-histochemistry assay",
                    "criterion": "stained cells by immuno-histochemistry assay",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. In case of multifocality, the histological size of the largest tumor must be ≤ 10 mm or ≤ 30 mm according to the inclusion subgroup. All lesions must be ER, PR and HER2-negative.",
            "criterions": [
                {
                    "exact_snippets": "multifocality",
                    "criterion": "multifocality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histological size of the largest tumor must be ≤ 10 mm or ≤ 30 mm according to the inclusion subgroup",
                    "criterion": "largest tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "mm"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "mm"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "All lesions must be ER, PR and HER2-negative",
                    "criterion": "ER status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "All lesions must be ER, PR and HER2-negative",
                    "criterion": "PR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "All lesions must be ER, PR and HER2-negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. In case of breast conserving surgery, clear margins are required.",
            "criterions": [
                {
                    "exact_snippets": "breast conserving surgery",
                    "criterion": "surgery type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast conserving"
                        }
                    ]
                },
                {
                    "exact_snippets": "clear margins are required",
                    "criterion": "surgical margins",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "clear"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient affiliated to a Social Health Insurance in France.",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated to a Social Health Insurance in France.",
                    "criterion": "Social Health Insurance affiliation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient affiliated to a Social Health Insurance in France.",
                    "criterion": "location",
                    "requirements": [
                        {
                            "requirement_type": "country",
                            "expected_value": "France"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patient information and written informed consent form signed prior to any study specific procedures.",
            "criterions": [
                {
                    "exact_snippets": "Patient information and written informed consent form signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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. Patients with any previous malignancy of the breast or other site, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer totally resected.",
            "criterions": [
                {
                    "exact_snippets": "Patients with any previous malignancy of the breast or other site",
                    "criterion": "previous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of adequately treated basal or squamous cell carcinoma",
                    "criterion": "adequately treated basal or squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanomatous skin cancer totally resected",
                    "criterion": "non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "resection status",
                            "expected_value": "totally resected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively).",
            "criterions": [
                {
                    "exact_snippets": "Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively)",
                    "criterion": "breast carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-invasive"
                        },
                        {
                            "requirement_type": "specific type",
                            "expected_value": "ductal carcinoma in situ"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Inoperable breast invasive carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Inoperable breast invasive carcinoma",
                    "criterion": "breast invasive carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Synchronous bilateral breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Synchronous bilateral breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "synchronous",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "bilateral",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery).",
            "criterions": [
                {
                    "exact_snippets": "Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery)",
                    "criterion": "neo-adjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. 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": "7. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.",
            "criterions": [
                {
                    "exact_snippets": "psychological ... potentially preventing the provision of informed consent or compliance to study procedure.",
                    "criterion": "psychological situation",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "potentially preventing informed consent or compliance"
                        }
                    ]
                },
                {
                    "exact_snippets": "familial ... potentially preventing the provision of informed consent or compliance to study procedure.",
                    "criterion": "familial situation",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "potentially preventing informed consent or compliance"
                        }
                    ]
                },
                {
                    "exact_snippets": "geographic ... potentially preventing the provision of informed consent or compliance to study procedure.",
                    "criterion": "geographic situation",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "potentially preventing informed consent or compliance"
                        }
                    ]
                },
                {
                    "exact_snippets": "social situation ... potentially preventing the provision of informed consent or compliance to study procedure.",
                    "criterion": "social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "potentially preventing informed consent or compliance"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "8. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.",
            "criterions": [
                {
                    "exact_snippets": "Patient who has forfeited his/her freedom by administrative or legal award",
                    "criterion": "freedom status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "forfeited by administrative or legal award"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient who is under guardianship",
                    "criterion": "guardianship status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under guardianship"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}