{
"info": {
"nct_id": "NCT00956280",
"official_title": "Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer",
"inclusion_criteria": "* Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)\n* Tumour sample (block of slides) available for KRAS analysis\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.\n* Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)",
"criterions": [
{
"exact_snippets": "Histological or cytological confirmation",
"criterion": "confirmation method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histological",
"cytological"
]
}
},
{
"exact_snippets": "locally advanced or metastatic Non Small Cell Lung Cancer",
"criterion": "Non Small Cell Lung Cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"metastatic"
]
}
},
{
"exact_snippets": "Non Small Cell Lung Cancer (IIIB-IV)",
"criterion": "Non Small Cell Lung Cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IIIB-IV"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histological or cytological confirmation",
"criterion": "confirmation method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histological",
"cytological"
]
}
},
{
"or_criteria": [
{
"exact_snippets": "locally advanced or metastatic Non Small Cell Lung Cancer",
"criterion": "Non Small Cell Lung Cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"metastatic"
]
}
},
{
"exact_snippets": "Non Small Cell Lung Cancer (IIIB-IV)",
"criterion": "Non Small Cell Lung Cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IIIB-IV"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Tumour sample (block of slides) available for KRAS analysis",
"criterions": [
{
"exact_snippets": "Tumour sample (block of slides) available",
"criterion": "tumour sample",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "KRAS analysis",
"criterion": "KRAS analysis",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Tumour sample (block of slides) available",
"criterion": "tumour sample",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "KRAS analysis",
"criterion": "KRAS analysis",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
}
},
{
"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 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"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.",
"criterions": [
{
"exact_snippets": "locally advanced or metastatic NSCLC (IIIB-IV)",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"IIIB",
"IV"
]
}
},
{
"exact_snippets": "exclusively by cytology",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "method",
"expected_value": "cytology"
}
},
{
"exact_snippets": "no tumour sample access",
"criterion": "tumour sample access",
"requirement": {
"requirement_type": "access",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)",
"criterions": [
{
"exact_snippets": "Previous treatment using a MEK inhibitor",
"criterion": "previous treatment with MEK inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "any other regimen containing docetaxel",
"criterion": "previous treatment with docetaxel",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "previous treatment with paclitaxel is accepted",
"criterion": "previous treatment with paclitaxel",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}