{
"info": {
"nct_id": "NCT00801320",
"official_title": "Study of Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Ovarian Spore)",
"inclusion_criteria": "* Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer as determined by a gynecologic oncologist\n* Patients are planning to undergo primary or secondary debulking surgery as part of standard of care for their disease\n* Estimated life expectancy of 6 months or greater\n* 18 years of age or older\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* More than one prior chemotherapy regimen\n* Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure\n* Known HIV infection\n* Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin\n* Significant autoimmune disease, including psoriasis\n* History of clinically significant venous thromboembolism",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer as determined by a gynecologic oncologist",
"criterions": [
{
"exact_snippets": "Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer",
"criterion": "advanced ovarian, fallopian tube or primary peritoneal cancer",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": true
}
]
},
{
"exact_snippets": "as determined by a gynecologic oncologist",
"criterion": "determination by a gynecologic oncologist",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients are planning to undergo primary or secondary debulking surgery as part of standard of care for their disease",
"criterions": [
{
"exact_snippets": "Patients are planning to undergo primary or secondary debulking surgery",
"criterion": "surgery type",
"requirements": [
{
"requirement_type": "planned",
"expected_value": [
"primary debulking surgery",
"secondary debulking surgery"
]
}
]
},
{
"exact_snippets": "as part of standard of care for their disease",
"criterion": "standard of care",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": true
}
]
}
]
},
{
"line": "* Estimated life expectancy of 6 months or greater",
"criterions": [
{
"exact_snippets": "Estimated life expectancy of 6 months or greater",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* 18 years of age or older",
"criterions": [
{
"exact_snippets": "18 years of age or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"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": "* More than one prior chemotherapy regimen",
"criterions": [
{
"exact_snippets": "More than one prior chemotherapy regimen",
"criterion": "prior chemotherapy regimens",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure",
"criterions": [
{
"exact_snippets": "Serious intercurrent illness such as infection requiring IV antibiotics",
"criterion": "serious intercurrent illness",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "infection requiring IV antibiotics",
"criterion": "infection",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "IV antibiotics"
}
]
},
{
"exact_snippets": "significant cardiac disease characterized by significant arrhythmia",
"criterion": "significant cardiac disease",
"requirements": [
{
"requirement_type": "characterization",
"expected_value": "significant arrhythmia"
}
]
},
{
"exact_snippets": "significant cardiac disease characterized by ... unstable ischemic coronary disease",
"criterion": "significant cardiac disease",
"requirements": [
{
"requirement_type": "characterization",
"expected_value": "unstable ischemic coronary disease"
}
]
},
{
"exact_snippets": "significant cardiac disease characterized by ... congestive heart failure",
"criterion": "significant cardiac disease",
"requirements": [
{
"requirement_type": "characterization",
"expected_value": "congestive heart failure"
}
]
}
]
},
{
"line": "* Known HIV infection",
"criterions": [
{
"exact_snippets": "Known HIV infection",
"criterion": "HIV infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin",
"criterions": [
{
"exact_snippets": "Active second malignancy",
"criterion": "second malignancy",
"requirements": [
{
"requirement_type": "activity",
"expected_value": true
}
]
},
{
"exact_snippets": "aside from basal cell or squamous cell carcinoma of the skin",
"criterion": "type of second malignancy",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": [
"basal cell carcinoma of the skin",
"squamous cell carcinoma of the skin"
]
}
]
}
]
},
{
"line": "* Significant autoimmune disease, including psoriasis",
"criterions": [
{
"exact_snippets": "Significant autoimmune disease",
"criterion": "autoimmune disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "significant"
}
]
},
{
"exact_snippets": "including psoriasis",
"criterion": "psoriasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of clinically significant venous thromboembolism",
"criterions": [
{
"exact_snippets": "History of clinically significant venous thromboembolism",
"criterion": "venous thromboembolism",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "clinical significance",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}