{
"info": {
"nct_id": "NCT03471572",
"official_title": "A Non-interventional, Multicentre Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India",
"inclusion_criteria": "1. Patients who provide written informed consent\n2. Female ≥ 18 years of age\n3. Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 130 Years",
"exclusion_criteria": "1. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patients who provide written informed consent",
"criterions": [
{
"exact_snippets": "Patients who provide written informed consent",
"criterion": "written informed consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who provide written informed consent",
"criterion": "written informed consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Female ≥ 18 years of age",
"criterions": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "female"
}
},
{
"exact_snippets": "≥ 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "female"
}
},
{
"exact_snippets": "≥ 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.",
"criterions": [
{
"exact_snippets": "Previously or newly diagnosed ovarian ... cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": [
"previously diagnosed",
"newly diagnosed"
]
}
},
{
"exact_snippets": "Previously or newly diagnosed ... primary peritoneal ... cancer",
"criterion": "primary peritoneal cancer",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": [
"previously diagnosed",
"newly diagnosed"
]
}
},
{
"exact_snippets": "Previously or newly diagnosed ... fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": [
"previously diagnosed",
"newly diagnosed"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Previously or newly diagnosed ovarian ... cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": [
"previously diagnosed",
"newly diagnosed"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Previously or newly diagnosed ... primary peritoneal ... cancer",
"criterion": "primary peritoneal cancer",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": [
"previously diagnosed",
"newly diagnosed"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Previously or newly diagnosed ... fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": [
"previously diagnosed",
"newly diagnosed"
]
}
}
]
}
]
}
},
{
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 130 Years",
"criterions": [
{
"exact_snippets": "maximum age of 130 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 130,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 130 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 130,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study",
"criterions": [
{
"exact_snippets": "any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study",
"criterion": "medical condition",
"requirement": {
"requirement_type": "interference with study completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study",
"criterion": "medical condition",
"requirement": {
"requirement_type": "interference with study completion",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}