{
    "info": {
        "nct_id": "NCT02830282",
        "official_title": "Surveillance Markers of Utility for Recurrence After Neoadjuvant Chemotherapy for Breast Cancer",
        "inclusion_criteria": "* Enrollment on the treatment phase of the I-SPY 2 TRIAL\n* Completed a standard neoadjuvant chemotherapy regimen or assigned treatment on I-SPY 2 and planning definitive surgical resection. Participants who have discontinued assigned treatment on I-SPY 2, switched to standard of care, and have completed a standard neoadjuvant chemotherapy regimen are still considered eligible.\n* Pre-surgical imaging or clinical examination demonstrating residual disease in the breast. Participants with any extent of enhancement attributable to tumor on the pre-surgical MRI are eligible. No minimum extent of palpable tumor pre-surgery is required.\n* Willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications\n* No clinical evidence of distant metastatic disease. Pre-chemotherapy staging scans are sufficient in the absence of any symptoms or subsequent clinical evidence suggesting distant metastases\n* Age 18 or over and are able to give informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Individuals under the age of 18\n* Individuals who cannot understand and give informed consent. We will not be assessing decisional capacity; determination of ability to give informed consent will be at the discretion of the treating physician.\n* Pregnancy. Participants in the parent I-SPY 2 TRIAL are screened for pregnancy at enrollment and pregnancy is an exclusion criteria. No additional screening for pregnancy is required for participants enrolling on SURMOUNT. However if a study participant does become pregnant while on study or during the course of the 10 year follow-up, the study participant will remain on the study protocol and will not be withdrawn. Because this is an observational study and does not have a therapeutic component, there will be no increased risk to following a study participant through annual blood draws and medical information abstraction from the medical chart who may or may not become pregnant during the course of the follow-up period.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Enrollment on the treatment phase of the I-SPY 2 TRIAL",
                "criterions": [
                    {
                        "exact_snippets": "Enrollment on the treatment phase of the I-SPY 2 TRIAL",
                        "criterion": "enrollment on treatment phase",
                        "requirement": {
                            "requirement_type": "trial",
                            "expected_value": "I-SPY 2 TRIAL"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Enrollment on the treatment phase of the I-SPY 2 TRIAL",
                        "criterion": "enrollment on treatment phase",
                        "requirement": {
                            "requirement_type": "trial",
                            "expected_value": "I-SPY 2 TRIAL"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Completed a standard neoadjuvant chemotherapy regimen or assigned treatment on I-SPY 2 and planning definitive surgical resection. Participants who have discontinued assigned treatment on I-SPY 2, switched to standard of care, and have completed a standard neoadjuvant chemotherapy regimen are still considered eligible.",
                "criterions": [
                    {
                        "exact_snippets": "Completed a standard neoadjuvant chemotherapy regimen",
                        "criterion": "neoadjuvant chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "assigned treatment on I-SPY 2",
                        "criterion": "I-SPY 2 treatment",
                        "requirement": {
                            "requirement_type": "assignment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "planning definitive surgical resection",
                        "criterion": "definitive surgical resection",
                        "requirement": {
                            "requirement_type": "planning",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Completed a standard neoadjuvant chemotherapy regimen",
                                        "criterion": "neoadjuvant chemotherapy regimen",
                                        "requirement": {
                                            "requirement_type": "completion",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "assigned treatment on I-SPY 2",
                                        "criterion": "I-SPY 2 treatment",
                                        "requirement": {
                                            "requirement_type": "assignment",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Completed a standard neoadjuvant chemotherapy regimen",
                                        "criterion": "neoadjuvant chemotherapy regimen",
                                        "requirement": {
                                            "requirement_type": "completion",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "assigned treatment on I-SPY 2",
                                        "criterion": "I-SPY 2 treatment",
                                        "requirement": {
                                            "requirement_type": "assignment",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "planning definitive surgical resection",
                        "criterion": "definitive surgical resection",
                        "requirement": {
                            "requirement_type": "planning",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pre-surgical imaging or clinical examination demonstrating residual disease in the breast. Participants with any extent of enhancement attributable to tumor on the pre-surgical MRI are eligible. No minimum extent of palpable tumor pre-surgery is required.",
                "criterions": [
                    {
                        "exact_snippets": "Pre-surgical imaging or clinical examination demonstrating residual disease in the breast.",
                        "criterion": "residual disease in the breast",
                        "requirement": {
                            "requirement_type": "demonstration",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Participants with any extent of enhancement attributable to tumor on the pre-surgical MRI are eligible.",
                        "criterion": "enhancement attributable to tumor on the pre-surgical MRI",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": "any"
                        }
                    },
                    {
                        "exact_snippets": "No minimum extent of palpable tumor pre-surgery is required.",
                        "criterion": "palpable tumor pre-surgery",
                        "requirement": {
                            "requirement_type": "minimum extent",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Pre-surgical imaging or clinical examination demonstrating residual disease in the breast.",
                                        "criterion": "residual disease in the breast",
                                        "requirement": {
                                            "requirement_type": "demonstration",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Participants with any extent of enhancement attributable to tumor on the pre-surgical MRI are eligible.",
                                        "criterion": "enhancement attributable to tumor on the pre-surgical MRI",
                                        "requirement": {
                                            "requirement_type": "extent",
                                            "expected_value": "any"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "No minimum extent of palpable tumor pre-surgery is required.",
                                "criterion": "palpable tumor pre-surgery",
                                "requirement": {
                                    "requirement_type": "minimum extent",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications",
                "criterions": [
                    {
                        "exact_snippets": "Willing to undergo bone marrow aspiration",
                        "criterion": "bone marrow aspiration",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing to undergo ... blood specimen collection",
                        "criterion": "blood specimen collection",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willing to undergo bone marrow aspiration",
                        "criterion": "bone marrow aspiration",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing to undergo ... blood specimen collection",
                        "criterion": "blood specimen collection",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No clinical evidence of distant metastatic disease. Pre-chemotherapy staging scans are sufficient in the absence of any symptoms or subsequent clinical evidence suggesting distant metastases",
                "criterions": [
                    {
                        "exact_snippets": "No clinical evidence of distant metastatic disease",
                        "criterion": "distant metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Pre-chemotherapy staging scans are sufficient in the absence of any symptoms or subsequent clinical evidence suggesting distant metastases",
                    "criterion": "symptoms or subsequent clinical evidence suggesting distant metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "exact_snippets": "No clinical evidence of distant metastatic disease",
                    "criterion": "distant metastatic disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Age 18 or over and are able to give informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Age 18 or over",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "able to give informed consent",
                        "criterion": "ability to give informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age 18 or over",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "able to give informed consent",
                        "criterion": "ability to give informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Individuals under the age of 18",
                "criterions": [
                    {
                        "exact_snippets": "under the age of 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "under the age of 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Individuals who cannot understand and give informed consent. We will not be assessing decisional capacity; determination of ability to give informed consent will be at the discretion of the treating physician.",
                "criterions": [
                    {
                        "exact_snippets": "cannot understand and give informed consent",
                        "criterion": "ability to give informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "cannot understand and give informed consent",
                        "criterion": "ability to give informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Pregnancy. Participants in the parent I-SPY 2 TRIAL are screened for pregnancy at enrollment and pregnancy is an exclusion criteria. No additional screening for pregnancy is required for participants enrolling on SURMOUNT. However if a study participant does become pregnant while on study or during the course of the 10 year follow-up, the study participant will remain on the study protocol and will not be withdrawn. Because this is an observational study and does not have a therapeutic component, there will be no increased risk to following a study participant through annual blood draws and medical information abstraction from the medical chart who may or may not become pregnant during the course of the follow-up period.",
                "criterions": [
                    {
                        "exact_snippets": "screened for pregnancy at enrollment",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "screening",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pregnancy is an exclusion criteria",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}