[96a5a0]: / output / allTrials / logical / NCT00368420_logical.json

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{
"info": {
"nct_id": "NCT00368420",
"official_title": "Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer",
"inclusion_criteria": "* Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy.\n* Women aged > 18 years\n* Patients who have given their signed and written informed consent to data transmission and -processing\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients with non-epithelial tumors as well as borderline tumors\n* Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval\n* Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer\n* Patients with a third recurrence\n* Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy.",
"criterions": [
{
"exact_snippets": "recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"invasive epithelial ovarian cancer",
"fallopian tube cancer",
"primary peritoneal cancer"
]
}
},
{
"exact_snippets": "any initial stage",
"criterion": "initial stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "any"
}
},
{
"exact_snippets": "relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy",
"criterion": "tumor-free interval after first-line therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "second relapse who are enrolled after completed platinum-containing re-induction therapy",
"criterion": "second relapse after platinum-containing re-induction therapy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"invasive epithelial ovarian cancer",
"fallopian tube cancer",
"primary peritoneal cancer"
]
}
},
{
"exact_snippets": "any initial stage",
"criterion": "initial stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "any"
}
}
]
},
{
"exact_snippets": "relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy",
"criterion": "tumor-free interval after first-line therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
},
{
"xor_criteria": [
{
"exact_snippets": "relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy",
"criterion": "tumor-free interval after first-line therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "second relapse who are enrolled after completed platinum-containing re-induction therapy",
"criterion": "second relapse after platinum-containing re-induction therapy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Women aged > 18 years",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": "female"
}
},
{
"exact_snippets": "aged > 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": "female"
}
},
{
"exact_snippets": "aged > 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have given their signed and written informed consent to data transmission and -processing",
"criterions": [
{
"exact_snippets": "Patients who have given their signed and written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "consent to data transmission and -processing",
"criterion": "consent to data transmission and processing",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who have given their signed and written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "consent to data transmission and -processing",
"criterion": "consent to data transmission and processing",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients with non-epithelial tumors as well as borderline tumors",
"criterions": [
{
"exact_snippets": "non-epithelial tumors",
"criterion": "tumor type",
"requirement": {
"requirement_type": "type",
"expected_value": "non-epithelial"
}
},
{
"exact_snippets": "borderline tumors",
"criterion": "tumor type",
"requirement": {
"requirement_type": "type",
"expected_value": "borderline"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "non-epithelial tumors",
"criterion": "tumor type",
"requirement": {
"requirement_type": "type",
"expected_value": "non-epithelial"
}
},
{
"exact_snippets": "borderline tumors",
"criterion": "tumor type",
"requirement": {
"requirement_type": "type",
"expected_value": "borderline"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval",
"criterions": [
{
"exact_snippets": "Patients who undergo second-look surgery",
"criterion": "second-look surgery",
"requirement": {
"requirement_type": "undergo",
"expected_value": true
}
},
{
"exact_snippets": "completion surgery after end of chemotherapy",
"criterion": "completion surgery",
"requirement": {
"requirement_type": "undergo",
"expected_value": true
}
},
{
"exact_snippets": "completion surgery ... during the interval",
"criterion": "completion surgery",
"requirement": {
"requirement_type": "undergo",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients who undergo second-look surgery",
"criterion": "second-look surgery",
"requirement": {
"requirement_type": "undergo",
"expected_value": true
}
},
{
"exact_snippets": "completion surgery after end of chemotherapy",
"criterion": "completion surgery",
"requirement": {
"requirement_type": "undergo",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Patients who undergo second-look surgery",
"criterion": "second-look surgery",
"requirement": {
"requirement_type": "undergo",
"expected_value": true
}
},
{
"exact_snippets": "completion surgery ... during the interval",
"criterion": "completion surgery",
"requirement": {
"requirement_type": "undergo",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients with a third recurrence",
"criterions": [
{
"exact_snippets": "third recurrence",
"criterion": "recurrence",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 3,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "third recurrence",
"criterion": "recurrence",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 3,
"unit": "N/A"
}
}
}
}
},
{
"identified_line": {
"line": "* Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy",
"criterions": [
{
"exact_snippets": "platinum-refractory tumor",
"criterion": "platinum-refractory tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "progression during chemotherapy",
"criterion": "tumor progression during chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "recurrence within 6 months after end of former platinum-containing therapy",
"criterion": "tumor recurrence after platinum-containing therapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "platinum-refractory tumor",
"criterion": "platinum-refractory tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "progression during chemotherapy",
"criterion": "tumor progression during chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "platinum-refractory tumor",
"criterion": "platinum-refractory tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "recurrence within 6 months after end of former platinum-containing therapy",
"criterion": "tumor recurrence after platinum-containing therapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer",
"criterions": [
{
"exact_snippets": "patients with second malignancies",
"criterion": "second malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "treated by laparotomy",
"criterion": "treatment by laparotomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other neoplasias",
"criterion": "other neoplasias",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "treatment could interfere with the treatment of relapsed ovarian cancer",
"criterion": "treatment interference with relapsed ovarian cancer",
"requirement": {
"requirement_type": "potential interference",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}