{
"info": {
"nct_id": "NCT04227457",
"official_title": "Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America",
"inclusion_criteria": "1. Patients aged 18 years or older;\n2. Newly diagnosed Non-Small Cell Lung Cancer (NSCLC) during the period of the study (which includes 3 months prior to site activation by LACOG, although they can have received anti-cancer treatment during that time);\n3. Histologically or cytologically confirmed advanced NSCLC:\n\n 1. Stage IIIB that progressed after curative therapy (chemoradiation and/or surgery);\n 2. Stage IV metastatic disease (de novo or distant relapse)\n4. Any NSCLC histological subtype and molecular mutation;\n5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;\n6. Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted agents, immunotherapy) or palliative care;\n7. Access to patient medical chart for data collection;\n8. Willing and able to provide written informed consent and privacy authorization for the release of personal health information.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patients aged 18 years or older;",
"criterions": [
{
"exact_snippets": "Patients aged 18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients aged 18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Newly diagnosed Non-Small Cell Lung Cancer (NSCLC) during the period of the study (which includes 3 months prior to site activation by LACOG, although they can have received anti-cancer treatment during that time);",
"criterions": [
{
"exact_snippets": "Newly diagnosed Non-Small Cell Lung Cancer (NSCLC)",
"criterion": "Non-Small Cell Lung Cancer (NSCLC)",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": "newly diagnosed"
}
},
{
"exact_snippets": "during the period of the study (which includes 3 months prior to site activation by LACOG",
"criterion": "diagnosis timing",
"requirement": {
"requirement_type": "time frame",
"expected_value": "during the period of the study (which includes 3 months prior to site activation by LACOG"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Newly diagnosed Non-Small Cell Lung Cancer (NSCLC)",
"criterion": "Non-Small Cell Lung Cancer (NSCLC)",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": "newly diagnosed"
}
},
{
"exact_snippets": "during the period of the study (which includes 3 months prior to site activation by LACOG",
"criterion": "diagnosis timing",
"requirement": {
"requirement_type": "time frame",
"expected_value": "during the period of the study (which includes 3 months prior to site activation by LACOG"
}
}
]
}
},
{
"identified_line": {
"line": "3. Histologically or cytologically confirmed advanced NSCLC:",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed",
"criterion": "NSCLC confirmation method",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "advanced NSCLC",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically or cytologically confirmed",
"criterion": "NSCLC confirmation method",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "advanced NSCLC",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
}
]
}
},
{
"identified_line": {
"line": "4. Any NSCLC histological subtype and molecular mutation;",
"criterions": [
{
"exact_snippets": "NSCLC histological subtype",
"criterion": "NSCLC histological subtype",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "molecular mutation",
"criterion": "molecular mutation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "NSCLC histological subtype",
"criterion": "NSCLC histological subtype",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "molecular mutation",
"criterion": "molecular mutation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4)",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 4,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4)",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 4,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "6. Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted agents, immunotherapy) or palliative care;",
"criterions": [
{
"exact_snippets": "Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted agents, immunotherapy)",
"criterion": "therapy assignment",
"requirement": {
"requirement_type": "assignment",
"expected_value": [
"chemotherapy",
"targeted agents",
"immunotherapy"
]
}
},
{
"exact_snippets": "Patients assigned by treating physician to ... palliative care",
"criterion": "palliative care assignment",
"requirement": {
"requirement_type": "assignment",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted agents, immunotherapy)",
"criterion": "therapy assignment",
"requirement": {
"requirement_type": "assignment",
"expected_value": [
"chemotherapy",
"targeted agents",
"immunotherapy"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Patients assigned by treating physician to ... palliative care",
"criterion": "palliative care assignment",
"requirement": {
"requirement_type": "assignment",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "7. Access to patient medical chart for data collection;",
"criterions": [
{
"exact_snippets": "Access to patient medical chart",
"criterion": "access to patient medical chart",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Access to patient medical chart",
"criterion": "access to patient medical chart",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "8. Willing and able to provide written informed consent and privacy authorization for the release of personal health information.",
"criterions": [
{
"exact_snippets": "Willing and able to provide written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willing and able to provide written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "privacy authorization for the release of personal health information",
"criterion": "privacy authorization",
"requirement": {
"requirement_type": "authorization",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Willing and able to provide written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willing and able to provide written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "privacy authorization for the release of personal health information",
"criterion": "privacy authorization",
"requirement": {
"requirement_type": "authorization",
"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": [
{
"identified_line": {
"line": "1. Stage IIIB that progressed after curative therapy (chemoradiation and/or surgery);",
"criterions": [
{
"exact_snippets": "Stage IIIB",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IIIB"
}
},
{
"exact_snippets": "progressed after curative therapy",
"criterion": "disease progression",
"requirement": {
"requirement_type": "progression status",
"expected_value": "progressed"
}
},
{
"exact_snippets": "curative therapy (chemoradiation and/or surgery)",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": [
"chemoradiation",
"surgery"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Stage IIIB",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IIIB"
}
},
{
"exact_snippets": "progressed after curative therapy",
"criterion": "disease progression",
"requirement": {
"requirement_type": "progression status",
"expected_value": "progressed"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "curative therapy (chemoradiation and/or surgery)",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "chemoradiation"
}
},
{
"exact_snippets": "curative therapy (chemoradiation and/or surgery)",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "surgery"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "2. Stage IV metastatic disease (de novo or distant relapse)",
"criterions": [
{
"exact_snippets": "Stage IV metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
},
{
"exact_snippets": "de novo or distant relapse",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "origin",
"expected_value": [
"de novo",
"distant relapse"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Stage IV metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
},
{
"or_criteria": [
{
"exact_snippets": "de novo or distant relapse",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "origin",
"expected_value": "de novo"
}
},
{
"exact_snippets": "de novo or distant relapse",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "origin",
"expected_value": "distant relapse"
}
}
]
}
]
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}