{
"info": {
"nct_id": "NCT04101760",
"official_title": "Long-acting Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study",
"inclusion_criteria": "* With definitive pathological results of epithelial ovarian cancer\n* With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2\n* Aged 18 or older\n* Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery\n* Regularly followed up in the study centers\n* Provided consent for participation.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Failure to meet all the inclusion criteria\n* Non-compliance with the study protocols\n* With a history of chemotherapy or pelvic radiotherapy for malignancies\n* Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome\n* Treated with weekly chemotherapy regimens\n* Presence of hematological disorders",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* With definitive pathological results of epithelial ovarian cancer",
"criterions": [
{
"exact_snippets": "definitive pathological results of epithelial ovarian cancer",
"criterion": "epithelial ovarian cancer",
"requirements": [
{
"requirement_type": "diagnosis confirmation",
"expected_value": "definitive pathological results"
}
]
}
]
},
{
"line": "* With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2",
"criterion": "ECOG performance status score",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Aged 18 or older",
"criterions": [
{
"exact_snippets": "Aged 18 or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery",
"criterions": [
{
"exact_snippets": "Receiving 3-4 weeks per cycle of platinum-based chemotherapy",
"criterion": "platinum-based chemotherapy",
"requirements": [
{
"requirement_type": "treatment duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
},
{
"operator": "<=",
"value": 4,
"unit": "weeks"
}
]
}
}
]
},
{
"exact_snippets": "with or without debulking surgery",
"criterion": "debulking surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"with",
"without"
]
}
]
}
]
},
{
"line": "* Regularly followed up in the study centers",
"criterions": [
{
"exact_snippets": "Regularly followed up in the study centers",
"criterion": "follow-up",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": "regularly"
},
{
"requirement_type": "location",
"expected_value": "study centers"
}
]
}
]
},
{
"line": "* Provided consent for participation.",
"criterions": [
{
"exact_snippets": "Provided consent for participation.",
"criterion": "consent for participation",
"requirements": [
{
"requirement_type": "provision",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"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": "* Failure to meet all the inclusion criteria",
"criterions": [
{
"exact_snippets": "Failure to meet all the inclusion criteria",
"criterion": "inclusion criteria",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
},
{
"line": "* Non-compliance with the study protocols",
"criterions": [
{
"exact_snippets": "Non-compliance with the study protocols",
"criterion": "compliance with study protocols",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
},
{
"line": "* With a history of chemotherapy or pelvic radiotherapy for malignancies",
"criterions": [
{
"exact_snippets": "history of chemotherapy",
"criterion": "chemotherapy history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "history of ... pelvic radiotherapy",
"criterion": "pelvic radiotherapy history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome",
"criterions": [
{
"exact_snippets": "Presence of immunosuppressive diseases such as organ transplantation",
"criterion": "immunosuppressive diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Presence of ... acquired immune deficiency syndrome",
"criterion": "acquired immune deficiency syndrome",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Treated with weekly chemotherapy regimens",
"criterions": [
{
"exact_snippets": "Treated with weekly chemotherapy regimens",
"criterion": "chemotherapy regimen",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": "weekly"
},
{
"requirement_type": "treatment status",
"expected_value": true
}
]
}
]
},
{
"line": "* Presence of hematological disorders",
"criterions": [
{
"exact_snippets": "Presence of hematological disorders",
"criterion": "hematological disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}