{
    "info": {
        "nct_id": "NCT03904173",
        "official_title": "Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer",
        "inclusion_criteria": "1. Written informed consent (informed consent document approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure\n2. Female or male age ≥ 18 years\n3. Able to comply with the protocol\n4. Primary surgery completed or if re-resection needed, a change from pT1 to pT2 categorization is not expected\n5. Histologically confirmed adenocarcinoma of the breast ≤ 5.0 cm in size (pT1-2) without metastasis to regional lymph nodes (pN0) or ≤ 20 mm in size (pT1) with lymph node micrometastases only (pN1mi)\n6. Primary tumor concluded as hormone receptor positive (ER ≥ 1%), HER2 negative.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Metastasis to regional lymph nodes or distant sites/organs.\n2. Previous treatment for localized breast cancer. Previous treatment for DCIS is allowed.\n3. HER2 positive\n4. ER and PgR negative tumor (< 1% expression)\n5. Other concomitant or earlier carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma and in situ cervix cancer\n6. Use of or participation in intervention trials testing treatment with any investigational anti-cancer drug. Participation in other types of intervention trials is allowed (such participation needs to be registered).\n7. Evidence of any other disease or condition that by the investigator is considered to impede follow-up of the patients.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Written informed consent (informed consent document approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent (informed consent document approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": "Independent Ethics Committee [IEC]"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to any study-specific procedure"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Female or male age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Female or male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "female",
                                "male"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Able to comply with the protocol",
            "criterions": [
                {
                    "exact_snippets": "Able to comply with the protocol",
                    "criterion": "protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Primary surgery completed or if re-resection needed, a change from pT1 to pT2 categorization is not expected",
            "criterions": [
                {
                    "exact_snippets": "Primary surgery completed",
                    "criterion": "primary surgery",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "re-resection needed",
                    "criterion": "re-resection",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "change from pT1 to pT2 categorization is not expected",
                    "criterion": "tumor categorization change",
                    "requirements": [
                        {
                            "requirement_type": "expectation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Histologically confirmed adenocarcinoma of the breast ≤ 5.0 cm in size (pT1-2) without metastasis to regional lymph nodes (pN0) or ≤ 20 mm in size (pT1) with lymph node micrometastases only (pN1mi)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the breast",
                    "criterion": "adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the breast ≤ 5.0 cm in size (pT1-2)",
                    "criterion": "adenocarcinoma of the breast size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without metastasis to regional lymph nodes (pN0)",
                    "criterion": "metastasis to regional lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the breast ... ≤ 20 mm in size (pT1)",
                    "criterion": "adenocarcinoma of the breast size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with lymph node micrometastases only (pN1mi)",
                    "criterion": "lymph node micrometastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Primary tumor concluded as hormone receptor positive (ER ≥ 1%), HER2 negative.",
            "criterions": [
                {
                    "exact_snippets": "Primary tumor concluded as hormone receptor positive (ER ≥ 1%)",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "estrogen receptor (ER) expression",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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. Metastasis to regional lymph nodes or distant sites/organs.",
            "criterions": [
                {
                    "exact_snippets": "Metastasis to regional lymph nodes",
                    "criterion": "metastasis to regional lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastasis to ... distant sites/organs",
                    "criterion": "metastasis to distant sites/organs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous treatment for localized breast cancer. Previous treatment for DCIS is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment for localized breast cancer.",
                    "criterion": "previous treatment for localized breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment for DCIS is allowed.",
                    "criterion": "previous treatment for DCIS",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. HER2 positive",
            "criterions": [
                {
                    "exact_snippets": "HER2 positive",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ER and PgR negative tumor (< 1% expression)",
            "criterions": [
                {
                    "exact_snippets": "ER and PgR negative tumor (< 1% expression)",
                    "criterion": "ER expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ER and PgR negative tumor (< 1% expression)",
                    "criterion": "PgR expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Other concomitant or earlier carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma and in situ cervix cancer",
            "criterions": [
                {
                    "exact_snippets": "Other concomitant or earlier carcinoma less than five years prior to the breast cancer diagnosis",
                    "criterion": "other carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... in situ cervix cancer",
                    "criterion": "in situ cervix cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Use of or participation in intervention trials testing treatment with any investigational anti-cancer drug. Participation in other types of intervention trials is allowed (such participation needs to be registered).",
            "criterions": [
                {
                    "exact_snippets": "Use of or participation in intervention trials testing treatment with any investigational anti-cancer drug.",
                    "criterion": "participation in intervention trials",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "testing treatment with any investigational anti-cancer drug"
                        },
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participation in other types of intervention trials is allowed",
                    "criterion": "participation in intervention trials",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other types"
                        },
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "such participation needs to be registered",
                    "criterion": "participation in intervention trials",
                    "requirements": [
                        {
                            "requirement_type": "registration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Evidence of any other disease or condition that by the investigator is considered to impede follow-up of the patients.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of any other disease or condition",
                    "criterion": "other disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}