{
"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": [
{
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"criterion": "cancer type",
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"fallopian tube cancer",
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]
}
},
{
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},
{
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"criterion": "tumor-free interval after first-line therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
},
{
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"criterion": "second relapse after platinum-containing re-induction therapy",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
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"exact_snippets": "recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer",
"criterion": "cancer type",
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]
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"criterion": "tumor-free interval after first-line therapy",
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"value": 6,
"unit": "months"
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"expected_value": true
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},
{
"identified_line": {
"line": "* Women aged > 18 years",
"criterions": [
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"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": {
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"value": 18,
"unit": "years"
}
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}
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},
"logical_structure": {
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"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
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},
{
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"unit": "years"
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{
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"criterions": [
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"requirement": {
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"expected_value": true
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},
{
"exact_snippets": "consent to data transmission and -processing",
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"requirement": {
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"expected_value": true
}
}
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"expected_value": true
}
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{
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"requirement": {
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"expected_value": true
}
}
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{
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"criterion": "volunteer health status",
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"expected_value": "healthy"
}
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},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
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}
}
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},
"logical_structure": {
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"requirement": {
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}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
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}
],
"exclusion_lines": [
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"identified_line": {
"line": "* Patients with non-epithelial tumors as well as borderline tumors",
"criterions": [
{
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"criterion": "tumor type",
"requirement": {
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}
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{
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{
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{
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"criterions": [
{
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"criterion": "second-look surgery",
"requirement": {
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"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": {
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"expected_value": true
}
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{
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"unit": "N/A"
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"unit": "months"
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{
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}