{
"info": {
"nct_id": "NCT02543710",
"official_title": "Biomarker Guided Treatment in Gynaecological Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 95 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion Criteria part 1:\n\nAll patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.\n\nExclusion Criteria part 1:\n\n1. Patients who do not have endometrial cancer\n2. Patients who will or cannot give informed consent (including language barriers)\n3. Patients <18 years of age\n4. Patients who will not get surgical treatment for their endometrial cancer\n\nInclusion criteria part 2:\n\n1. Patients with endometrial or epithelial ovarian cancer who following routine clinical guidelines are offered weekly taxane (paclitaxel) treatment. This will often be a third or fourth line treatment, i.e. patients with advanced disease.\n2. Technical possibility to obtain a new tissue biopsy to determine stathmin level in the tumour recurrence.\n\nExclusion criteria part 2:\n\n1. Patients not suffering from endometrial or epithelial ovarian cancer\n2. Patients <18 years of age\n3. Patients who do not agree to the proposed treatment or will receive (part of) the treatment in a non-participating centre\n4. Patients who cannot or do not want to give informed consent (including language barriers)"
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": [
"Must be FEMALE"
],
"criterion": "gender",
"requirement_type": "specific value",
"expected_value": "female"
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
{
"line": "Must have maximum age of 95 Years",
"criterions": [
{
"exact_snippets": [
"maximum age of 95 Years"
],
"criterion": "age",
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 95
}
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.",
"criterions": [
{
"exact_snippets": [
"suspicion of",
"endometrial cancer"
],
"criterion": "endometrial cancer",
"requirement_type": "suspicion",
"expected_value": true
},
{
"exact_snippets": [
"confirmed",
"endometrial cancer"
],
"criterion": "endometrial cancer",
"requirement_type": "confirmation",
"expected_value": true
}
]
},
{
"line": "1. Patients who do not have endometrial cancer",
"criterions": [
{
"exact_snippets": [
"do not have endometrial cancer"
],
"criterion": "endometrial cancer",
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"line": "2. Patients who will or cannot give informed consent (including language barriers)",
"criterions": [
{
"exact_snippets": [
"Patients who will or cannot give informed consent"
],
"criterion": "informed consent",
"requirement_type": "ability to give",
"expected_value": true
},
{
"exact_snippets": [
"language barriers"
],
"criterion": "language barriers",
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"line": "3. Patients <18 years of age",
"criterions": [
{
"exact_snippets": [
"<18 years of age"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18
}
]
}
}
]
},
{
"line": "4. Patients who will not get surgical treatment for their endometrial cancer",
"criterions": [
{
"exact_snippets": [
"Patients who will not get surgical treatment"
],
"criterion": "surgical treatment",
"requirement_type": "intention",
"expected_value": false
},
{
"exact_snippets": [
"endometrial cancer"
],
"criterion": "endometrial cancer",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "1. Patients with endometrial or epithelial ovarian cancer who following routine clinical guidelines are offered weekly taxane (paclitaxel) treatment. This will often be a third or fourth line treatment, i.e. patients with advanced disease.",
"criterions": [
{
"exact_snippets": [
"endometrial or epithelial ovarian cancer"
],
"criterion": "cancer type",
"requirement_type": "presence",
"expected_value": [
"endometrial",
"epithelial ovarian"
]
},
{
"exact_snippets": [
"weekly taxane (paclitaxel) treatment"
],
"criterion": "taxane (paclitaxel) treatment",
"requirement_type": "frequency",
"expected_value": "weekly"
},
{
"exact_snippets": [
"third or fourth line treatment"
],
"criterion": "treatment line",
"requirement_type": "order",
"expected_value": [
"third",
"fourth"
]
},
{
"exact_snippets": [
"advanced disease"
],
"criterion": "disease stage",
"requirement_type": "severity",
"expected_value": "advanced"
}
]
},
{
"line": "2. Technical possibility to obtain a new tissue biopsy to determine stathmin level in the tumour recurrence.",
"criterions": [
{
"exact_snippets": [
"Technical possibility to obtain a new tissue biopsy"
],
"criterion": "tissue biopsy",
"requirement_type": "obtainability",
"expected_value": true
},
{
"exact_snippets": [
"stathmin level in the tumour recurrence"
],
"criterion": "stathmin level",
"requirement_type": "measurement",
"expected_value": "tumour recurrence"
}
]
},
{
"line": "1. Patients not suffering from endometrial or epithelial ovarian cancer",
"criterions": [
{
"exact_snippets": [
"not suffering from endometrial"
],
"criterion": "endometrial cancer",
"requirement_type": "presence",
"expected_value": false
},
{
"exact_snippets": [
"not suffering from",
"epithelial ovarian cancer"
],
"criterion": "epithelial ovarian cancer",
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"line": "2. Patients <18 years of age",
"criterions": [
{
"exact_snippets": [
"<18 years of age"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18
}
]
}
}
]
},
{
"line": "3. Patients who do not agree to the proposed treatment or will receive (part of) the treatment in a non-participating centre",
"criterions": [
{
"exact_snippets": [
"Patients who do not agree to the proposed treatment"
],
"criterion": "agreement to proposed treatment",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"will receive (part of) the treatment in a non-participating centre"
],
"criterion": "treatment location",
"requirement_type": "location",
"expected_value": "participating centre"
}
]
},
{
"line": "4. Patients who cannot or do not want to give informed consent (including language barriers)",
"criterions": [
{
"exact_snippets": [
"cannot or do not want to give informed consent"
],
"criterion": "informed consent",
"requirement_type": "ability/willingness",
"expected_value": false
},
{
"exact_snippets": [
"language barriers"
],
"criterion": "language barriers",
"requirement_type": "presence",
"expected_value": true
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "Inclusion Criteria part 1:",
"criterions": []
},
{
"line": "Exclusion Criteria part 1:",
"criterions": []
},
{
"line": "Inclusion criteria part 2:",
"criterions": []
},
{
"line": "Exclusion criteria part 2:",
"criterions": []
}
]
}