{
"info": {
"nct_id": "NCT05763472",
"official_title": "Molecular Landscape Involved in the Onset of Breast Cancer in Patients With Germline BRCA-1/2 Mutations, During or After Therapy With Platinum-based Agents and/or PARP-inhibitors for Ovarian Cancer",
"inclusion_criteria": "* Written informed consent.\n* Age older than 18 years.\n* Germline BRCA1/2 mutation.\n* Histologically confirmed ovarian cancer treated with platinum-based chemotherapy and/or PARP inhibitors.\n* Histologically confirmed breast cancer occurred during or after therapy with platinum-based agents and/or PARP-inhibitors for ovarian cancer.\n* Availability of FFPE breast and ovarian tumor samples.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Other malignancies in the last 2 years.\n* Prior chemotherapy or radiation therapy for other malignancies.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Written informed consent.",
"criterions": [
{
"exact_snippets": "Written informed consent.",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Age older than 18 years.",
"criterions": [
{
"exact_snippets": "Age older than 18 years.",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Germline BRCA1/2 mutation.",
"criterions": [
{
"exact_snippets": "Germline BRCA1/2 mutation",
"criterion": "germline BRCA1/2 mutation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Histologically confirmed ovarian cancer treated with platinum-based chemotherapy and/or PARP inhibitors.",
"criterions": [
{
"exact_snippets": "Histologically confirmed ovarian cancer",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "treated with platinum-based chemotherapy",
"criterion": "treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "platinum-based chemotherapy"
}
]
},
{
"exact_snippets": "treated with ... PARP inhibitors",
"criterion": "treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "PARP inhibitors"
}
]
}
]
},
{
"line": "* Histologically confirmed breast cancer occurred during or after therapy with platinum-based agents and/or PARP-inhibitors for ovarian cancer.",
"criterions": [
{
"exact_snippets": "Histologically confirmed breast cancer",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "occurred during or after therapy with platinum-based agents",
"criterion": "therapy with platinum-based agents",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "during or after"
}
]
},
{
"exact_snippets": "occurred during or after therapy with ... PARP-inhibitors",
"criterion": "therapy with PARP-inhibitors",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "during or after"
}
]
},
{
"exact_snippets": "therapy with platinum-based agents and/or PARP-inhibitors for ovarian cancer",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": [
"platinum-based agents",
"PARP-inhibitors"
]
}
]
}
]
},
{
"line": "* Availability of FFPE breast and ovarian tumor samples.",
"criterions": [
{
"exact_snippets": "Availability of FFPE breast and ovarian tumor samples.",
"criterion": "FFPE breast tumor samples",
"requirements": [
{
"requirement_type": "availability",
"expected_value": true
}
]
},
{
"exact_snippets": "Availability of FFPE breast and ovarian tumor samples.",
"criterion": "FFPE ovarian tumor samples",
"requirements": [
{
"requirement_type": "availability",
"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 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": "* Other malignancies in the last 2 years.",
"criterions": [
{
"exact_snippets": "Other malignancies in the last 2 years.",
"criterion": "other malignancies",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Prior chemotherapy or radiation therapy for other malignancies.",
"criterions": [
{
"exact_snippets": "Prior chemotherapy ... for other malignancies.",
"criterion": "prior chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Prior ... radiation therapy for other malignancies.",
"criterion": "prior radiation therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}