{
"info": {
"nct_id": "NCT02557776",
"official_title": "BRCAsearch: A Population Based Prospective Study on Screening for BRCA1 and BRCA2 Germline Mutations in Patients With Newly Diagnosed Breast Cancer Treated in Southern Sweden.",
"inclusion_criteria": "1. The patient is included in the SCAN-B study.\n2. The patient is recently diagnosed with an invasive breast cancer or a ductal cancer in situ.\n3. The patient has signed an informed consent form.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. The patient is unable to understand the written information in Swedish.\n2. The patient's psychological state, due to chronic och temporary reasons, is such that one could suspect that information about the study or genetic testing could be substantially detrimental to the psychological well-beeing.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. The patient is included in the SCAN-B study.",
"criterions": [
{
"exact_snippets": "The patient is included in the SCAN-B study.",
"criterion": "SCAN-B study inclusion",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": true
}
]
}
]
},
{
"line": "2. The patient is recently diagnosed with an invasive breast cancer or a ductal cancer in situ.",
"criterions": [
{
"exact_snippets": "recently diagnosed with an invasive breast cancer",
"criterion": "invasive breast cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "recent"
}
]
},
{
"exact_snippets": "recently diagnosed with ... ductal cancer in situ",
"criterion": "ductal cancer in situ",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "recent"
}
]
}
]
},
{
"line": "3. The patient has signed an informed consent form.",
"criterions": [
{
"exact_snippets": "The patient has signed an informed consent form.",
"criterion": "informed consent form",
"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 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. The patient is unable to understand the written information in Swedish.",
"criterions": [
{
"exact_snippets": "unable to understand the written information in Swedish",
"criterion": "understanding of written information in Swedish",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "2. The patient's psychological state, due to chronic och temporary reasons, is such that one could suspect that information about the study or genetic testing could be substantially detrimental to the psychological well-beeing.",
"criterions": [
{
"exact_snippets": "The patient's psychological state, due to chronic och temporary reasons, is such that one could suspect that information about the study or genetic testing could be substantially detrimental to the psychological well-beeing.",
"criterion": "psychological state",
"requirements": [
{
"requirement_type": "impact of study information",
"expected_value": "substantially detrimental to psychological well-being"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}