{
"info": {
"nct_id": "NCT02890082",
"official_title": "Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer",
"inclusion_criteria": "* Aged between 18 and 40\n* infiltrating breast carcinoma histologically proven\n* Indication of adjuvant or neoadjuvant chemotherapy\n* T0-T1-T2-T3\n* N0-N1-N2a\n* M0 after staging\n* AMH ≥1 ng / mL and / or account antral follicles ≥ 5\n* HIV serology negative.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 40 Years",
"exclusion_criteria": "* breast cancer history\n* History of another cancer in the last 5 years, with the exception of basal cell skin cancer and squamous cell\n* patient in pregnancy\n* pulmonary embolism under 6 months\n* deep vein thrombosis of less than 6 months.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Aged between 18 and 40",
"criterions": [
{
"exact_snippets": "Aged between 18 and 40",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 40,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* infiltrating breast carcinoma histologically proven",
"criterions": [
{
"exact_snippets": "infiltrating breast carcinoma",
"criterion": "breast carcinoma",
"requirements": [
{
"requirement_type": "type",
"expected_value": "infiltrating"
}
]
},
{
"exact_snippets": "histologically proven",
"criterion": "histological proof",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Indication of adjuvant or neoadjuvant chemotherapy",
"criterions": [
{
"exact_snippets": "Indication of adjuvant or neoadjuvant chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "indication",
"expected_value": [
"adjuvant",
"neoadjuvant"
]
}
]
}
]
},
{
"line": "* T0-T1-T2-T3",
"criterions": [
{
"exact_snippets": "T0-T1-T2-T3",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"T0",
"T1",
"T2",
"T3"
]
}
]
}
]
},
{
"line": "* N0-N1-N2a",
"criterions": [
{
"exact_snippets": "N0-N1-N2a",
"criterion": "lymph node involvement",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"N0",
"N1",
"N2a"
]
}
]
}
]
},
{
"line": "* M0 after staging",
"criterions": [
{
"exact_snippets": "M0 after staging",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "M0"
}
]
}
]
},
{
"line": "* AMH ≥1 ng / mL and / or account antral follicles ≥ 5",
"criterions": [
{
"exact_snippets": "AMH ≥1 ng / mL",
"criterion": "AMH level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "ng/mL"
}
}
]
},
{
"exact_snippets": "account antral follicles ≥ 5",
"criterion": "antral follicle count",
"requirements": [
{
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* HIV serology negative.",
"criterions": [
{
"exact_snippets": "HIV serology negative",
"criterion": "HIV serology",
"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 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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 40 Years",
"criterions": [
{
"exact_snippets": "maximum age of 40 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 40,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* breast cancer history",
"criterions": [
{
"exact_snippets": "breast cancer history",
"criterion": "breast cancer history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of another cancer in the last 5 years, with the exception of basal cell skin cancer and squamous cell",
"criterions": [
{
"exact_snippets": "History of another cancer in the last 5 years",
"criterion": "history of another cancer",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "with the exception of basal cell skin cancer and squamous cell",
"criterion": "type of cancer",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": [
"basal cell skin cancer",
"squamous cell"
]
}
]
}
]
},
{
"line": "* patient in pregnancy",
"criterions": [
{
"exact_snippets": "patient in pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* pulmonary embolism under 6 months",
"criterions": [
{
"exact_snippets": "pulmonary embolism under 6 months",
"criterion": "pulmonary embolism",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* deep vein thrombosis of less than 6 months.",
"criterions": [
{
"exact_snippets": "deep vein thrombosis of less than 6 months",
"criterion": "deep vein thrombosis",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}