{
    "info": {
        "nct_id": "NCT04362462",
        "official_title": "Genomic/Molecular Profiling of Residual Disease After Neoadjuvant Chemotherapy in Hispanic/ Latino Women With Triple-negative Breast Cancer",
        "inclusion_criteria": "1. Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the ethnonyms \"Hispanic\" and \"Latino\" to refer collectively to the inhabitants of the United States of America who are of Latin American or Spanish origin-that is, Latino or Hispanic Americans).\n2. Pre- and Post - menopausal women with histologically confirmed hormonal receptor negative (ER and/or PR <1%), Her2-neu - negative (by IHC or/and FISH) invasive breast cancer stages I - III or with metastatic triple-negative breast cancer (if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments).\n3. Patient must be eligible for neo-adjuvant chemotherapy, and surgical lumpectomy or mastectomy.\n4. All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with Institutional and Federal guidelines.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 86 Years",
        "exclusion_criteria": "1. Women < 18 or >86 years of age\n2. ER/PR- positive, Her-2 neu - positive breast cancer.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the ethnonyms \"Hispanic\" and \"Latino\" to refer collectively to the inhabitants of the United States of America who are of Latin American or Spanish origin-that is, Latino or Hispanic Americans).",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 or <86 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 86,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hispanic/Latino women",
                    "criterion": "ethnicity",
                    "requirements": [
                        {
                            "requirement_type": "ethnic group",
                            "expected_value": [
                                "Hispanic",
                                "Latino"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pre- and Post - menopausal women with histologically confirmed hormonal receptor negative (ER and/or PR <1%), Her2-neu - negative (by IHC or/and FISH) invasive breast cancer stages I - III or with metastatic triple-negative breast cancer (if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments).",
            "criterions": [
                {
                    "exact_snippets": "Pre- and Post - menopausal women",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "pre-menopausal",
                                "post-menopausal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed hormonal receptor negative (ER and/or PR <1%)",
                    "criterion": "hormonal receptor status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "ER and/or PR",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Her2-neu - negative (by IHC or/and FISH)",
                    "criterion": "Her2-neu status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "IHC",
                                "FISH"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "invasive breast cancer stages I - III",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic triple-negative breast cancer",
                    "criterion": "breast cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "metastatic triple-negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments",
                    "criterion": "metastatic disease development timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during chemotherapy or within 24 months after completion of all appropriate treatments"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient must be eligible for neo-adjuvant chemotherapy, and surgical lumpectomy or mastectomy.",
            "criterions": [
                {
                    "exact_snippets": "eligible for neo-adjuvant chemotherapy",
                    "criterion": "neo-adjuvant chemotherapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for ... surgical lumpectomy or mastectomy",
                    "criterion": "surgical procedure eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": [
                                "lumpectomy",
                                "mastectomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with Institutional and Federal guidelines.",
            "criterions": [
                {
                    "exact_snippets": "All patients or their legally authorized representative must be informed of the investigational nature of this study",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "information",
                            "expected_value": "investigational nature of this study"
                        }
                    ]
                },
                {
                    "exact_snippets": "must sign and give written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "written"
                        }
                    ]
                },
                {
                    "exact_snippets": "in accordance with Institutional and Federal guidelines",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": [
                                "Institutional guidelines",
                                "Federal guidelines"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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 86 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 86 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 86,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Women < 18 or >86 years of age",
            "criterions": [
                {
                    "exact_snippets": "Women < 18 or >86 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 86,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ER/PR- positive, Her-2 neu - positive breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "ER/PR- positive",
                    "criterion": "ER/PR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Her-2 neu - positive",
                    "criterion": "Her-2 neu status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}