{
"info": {
"nct_id": "NCT03071848",
"official_title": "Retrospective Multicenter Observational Study to Evaluate Safety and Effectiveness of Bevacizumab (Avastin®) in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Patients With Advanced Cervical Cancer",
"inclusion_criteria": "* Age 18 or older\n* Diagnosis of primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy\n* Retrospective clinical decision made to initiate therapy with bevacizumab (Avastin®) combined with standard chemotherapy (cisplatin or carboplatin or topotecan and paclitaxel) between 01 January 2015 and 01 January 2016\n* All participants must have received at least one dose of bevacizumab combined with standard chemotherapy between 01 January 2015 and 01 January 2016 AND have at least 12 months of documented follow up, from treatment start, unless died or lost to follow up within the minimum study entry follow up period\n* Availability of documentation of for advanced cervical cancer (including prior treatment as applicable) and follow up in the participant's medical records\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Participation during the study period in an interventional clinical trial or any other interventional study that may impact advanced cervical cancer outcome\n* Participants who have received prior therapy with any anti-VEGF drug, including bevacizumab",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age 18 or older",
"criterions": [
{
"exact_snippets": "Age 18 or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Diagnosis of primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy",
"criterions": [
{
"exact_snippets": "Diagnosis of primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix",
"criterion": "cervical cancer type and stage",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"squamous cell carcinoma",
"adenosquamous carcinoma",
"adenocarcinoma"
]
},
{
"requirement_type": "stage",
"expected_value": "IVB"
},
{
"requirement_type": "recurrence",
"expected_value": true
},
{
"requirement_type": "persistence",
"expected_value": true
}
]
},
{
"exact_snippets": "not amenable to curative treatment with surgery and/or radiation therapy",
"criterion": "treatment amenability",
"requirements": [
{
"requirement_type": "curative treatment",
"expected_value": false
}
]
}
]
},
{
"line": "* Retrospective clinical decision made to initiate therapy with bevacizumab (Avastin®) combined with standard chemotherapy (cisplatin or carboplatin or topotecan and paclitaxel) between 01 January 2015 and 01 January 2016",
"criterions": [
{
"exact_snippets": "Retrospective clinical decision made to initiate therapy with bevacizumab (Avastin®)",
"criterion": "therapy initiation with bevacizumab",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "combined with standard chemotherapy (cisplatin or carboplatin or topotecan and paclitaxel)",
"criterion": "standard chemotherapy combination",
"requirements": [
{
"requirement_type": "components",
"expected_value": [
"cisplatin",
"carboplatin",
"topotecan",
"paclitaxel"
]
}
]
},
{
"exact_snippets": "between 01 January 2015 and 01 January 2016",
"criterion": "therapy initiation date",
"requirements": [
{
"requirement_type": "date range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 20150101,
"unit": "YYYYMMDD"
},
{
"operator": "<=",
"value": 20160101,
"unit": "YYYYMMDD"
}
]
}
}
]
}
]
},
{
"line": "* All participants must have received at least one dose of bevacizumab combined with standard chemotherapy between 01 January 2015 and 01 January 2016 AND have at least 12 months of documented follow up, from treatment start, unless died or lost to follow up within the minimum study entry follow up period",
"criterions": [
{
"exact_snippets": "received at least one dose of bevacizumab",
"criterion": "bevacizumab treatment",
"requirements": [
{
"requirement_type": "dose",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "dose"
}
}
]
},
{
"exact_snippets": "combined with standard chemotherapy",
"criterion": "standard chemotherapy",
"requirements": [
{
"requirement_type": "combination",
"expected_value": true
}
]
},
{
"exact_snippets": "between 01 January 2015 and 01 January 2016",
"criterion": "treatment period",
"requirements": [
{
"requirement_type": "date range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 20150101,
"unit": "date"
},
{
"operator": "<=",
"value": 20160101,
"unit": "date"
}
]
}
}
]
},
{
"exact_snippets": "at least 12 months of documented follow up",
"criterion": "documented follow up",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
]
},
{
"exact_snippets": "unless died or lost to follow up within the minimum study entry follow up period",
"criterion": "follow up exception",
"requirements": [
{
"requirement_type": "condition",
"expected_value": [
"died",
"lost to follow up"
]
}
]
}
]
},
{
"line": "* Availability of documentation of for advanced cervical cancer (including prior treatment as applicable) and follow up in the participant's medical records",
"criterions": [
{
"exact_snippets": "Availability of documentation of for advanced cervical cancer",
"criterion": "documentation of advanced cervical cancer",
"requirements": [
{
"requirement_type": "availability",
"expected_value": true
}
]
},
{
"exact_snippets": "follow up in the participant's medical records",
"criterion": "follow up in medical records",
"requirements": [
{
"requirement_type": "availability",
"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 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": "* Participation during the study period in an interventional clinical trial or any other interventional study that may impact advanced cervical cancer outcome",
"criterions": [
{
"exact_snippets": "Participation during the study period in an interventional clinical trial",
"criterion": "participation in interventional clinical trial",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Participation during the study period in ... any other interventional study that may impact advanced cervical cancer outcome",
"criterion": "participation in interventional study impacting cervical cancer outcome",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Participants who have received prior therapy with any anti-VEGF drug, including bevacizumab",
"criterions": [
{
"exact_snippets": "received prior therapy with any anti-VEGF drug, including bevacizumab",
"criterion": "prior anti-VEGF therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}