{
    "info": {
        "nct_id": "NCT03672331",
        "official_title": "International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70",
        "inclusion_criteria": "1. Female (whether born female or not)\n2. Aged 40 to 70 years old (inclusive)\n3. Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures\n4. Able to provide written informed consent obtained prior to performing any protocol-related procedures\n5. Sufficient understanding of any of the languages used in the study\n6. Affiliated to a social security/national healthcare system\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 40 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS)\n2. Prior history of atypical breast lesion, lobular carcinoma in situ or chest wall irradiation\n3. Known condition or suspicion of a very high risk predisposition to breast cancer: germline mutation of BRCA1/2, PALB2, TP53 or equivalent\n4. History of bilateral mastectomy\n5. Recent abnormal breast finding under work-up (clinically suspect lesion or BI-RADS 4 or 5 image)\n6. Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up\n7. Women who do not intend to be followed-up for 4 years",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Female (whether born female or not)",
            "criterions": [
                {
                    "exact_snippets": "Female (whether born female or not)",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Aged 40 to 70 years old (inclusive)",
            "criterions": [
                {
                    "exact_snippets": "Aged 40 to 70 years old (inclusive)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 40,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to comply with ... other trial procedures",
                    "criterion": "compliance with other trial procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Able to provide written informed consent obtained prior to performing any protocol-related procedures",
            "criterions": [
                {
                    "exact_snippets": "Able to provide written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Sufficient understanding of any of the languages used in the study",
            "criterions": [
                {
                    "exact_snippets": "Sufficient understanding of any of the languages used in the study",
                    "criterion": "language understanding",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Affiliated to a social security/national healthcare system",
            "criterions": [
                {
                    "exact_snippets": "Affiliated to a social security/national healthcare system",
                    "criterion": "affiliation to a healthcare system",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "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 40 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 40 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS)",
            "criterions": [
                {
                    "exact_snippets": "Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS)",
                    "criterion": "breast carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "invasive",
                                "ductal carcinoma in situ (DCIS)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior history of atypical breast lesion, lobular carcinoma in situ or chest wall irradiation",
            "criterions": [
                {
                    "exact_snippets": "Prior history of atypical breast lesion",
                    "criterion": "atypical breast lesion",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior history of ... lobular carcinoma in situ",
                    "criterion": "lobular carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior history of ... chest wall irradiation",
                    "criterion": "chest wall irradiation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Known condition or suspicion of a very high risk predisposition to breast cancer: germline mutation of BRCA1/2, PALB2, TP53 or equivalent",
            "criterions": [
                {
                    "exact_snippets": "Known condition or suspicion of a very high risk predisposition to breast cancer",
                    "criterion": "predisposition to breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "very high"
                        }
                    ]
                },
                {
                    "exact_snippets": "germline mutation of BRCA1/2, PALB2, TP53 or equivalent",
                    "criterion": "germline mutation",
                    "requirements": [
                        {
                            "requirement_type": "genes",
                            "expected_value": [
                                "BRCA1",
                                "BRCA2",
                                "PALB2",
                                "TP53",
                                "equivalent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of bilateral mastectomy",
            "criterions": [
                {
                    "exact_snippets": "History of bilateral mastectomy",
                    "criterion": "bilateral mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Recent abnormal breast finding under work-up (clinically suspect lesion or BI-RADS 4 or 5 image)",
            "criterions": [
                {
                    "exact_snippets": "Recent abnormal breast finding under work-up",
                    "criterion": "abnormal breast finding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under work-up"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically suspect lesion",
                    "criterion": "clinically suspect lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "BI-RADS 4 or 5 image",
                    "criterion": "BI-RADS image",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": [
                                "4",
                                "5"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up",
                    "criterion": "psychiatric or other disorders",
                    "requirements": [
                        {
                            "requirement_type": "compatibility with compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Women who do not intend to be followed-up for 4 years",
            "criterions": [
                {
                    "exact_snippets": "Women who do not intend to be followed-up for 4 years",
                    "criterion": "follow-up intention",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}