{
"info": {
"nct_id": "NCT02163720",
"official_title": "Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse",
"inclusion_criteria": "* Patients aged 18 years and over,\n* Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive\n* Patients should be informed of the study orally and should not have any objection their data to be processed\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patient participation in a clinical trial\n* Patient non-affiliated to a social security scheme.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients aged 18 years and over,",
"criterions": [
{
"exact_snippets": "Patients aged 18 years and over",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive",
"criterions": [
{
"exact_snippets": "epithelial ovarian cancer",
"criterion": "epithelial ovarian cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "fallopian tube",
"criterion": "fallopian tube cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "peritoneal",
"criterion": "peritoneal cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "relapse platinum-sensitive",
"criterion": "platinum sensitivity",
"requirements": [
{
"requirement_type": "sensitivity",
"expected_value": "relapse platinum-sensitive"
}
]
}
]
},
{
"line": "* Patients should be informed of the study orally and should not have any objection their data to be processed",
"criterions": [
{
"exact_snippets": "Patients should be informed of the study orally",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "method",
"expected_value": "orally"
}
]
},
{
"exact_snippets": "should not have any objection their data to be processed",
"criterion": "data processing consent",
"requirements": [
{
"requirement_type": "objection",
"expected_value": false
}
]
}
]
},
{
"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": "* Patient participation in a clinical trial",
"criterions": [
{
"exact_snippets": "Patient participation in a clinical trial",
"criterion": "clinical trial participation",
"requirements": [
{
"requirement_type": "participation",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient non-affiliated to a social security scheme.",
"criterions": [
{
"exact_snippets": "Patient non-affiliated to a social security scheme",
"criterion": "social security scheme affiliation",
"requirements": [
{
"requirement_type": "affiliation",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}