{
"info": {
"nct_id": "NCT02222194",
"official_title": "Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR",
"inclusion_criteria": "(Suspected) NSCLC Medical operable and surgical resectable cT1, cT2 selected cT3 (i.e. intraparenchymal tumour >7cm, T3 chest wall, or T3 based on additional nodule in the lobe of the primary tumour) cN1 based on CT or PET 18 years or older Informed Consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "History of mediastinoscopy No integrated FDG PET/CT available No videomediastinoscopy available EBUS/EUS for mediastinal staging of present N1 disease cN2: mediastinal nodes enlarged on CT or Pet positive invasion of mediastinal pleura invasion of phrenic nerve invasion of parietal pericardium tumour in main bronchus less than 2cm form the main carina cT4 cM1 former therapy for lung cancer (chemotherapy, radiotherapy, surgery) technical contraindication for videomediastinoscopy ( eg extreme kyphosis, cutaneous tracheostomy, extreme goiter) pregnancy inability to consent",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "(Suspected) NSCLC Medical operable and surgical resectable cT1, cT2 selected cT3 (i.e. intraparenchymal tumour >7cm, T3 chest wall, or T3 based on additional nodule in the lobe of the primary tumour) cN1 based on CT or PET 18 years or older Informed Consent",
"criterions": [
{
"exact_snippets": "(Suspected) NSCLC",
"criterion": "NSCLC",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Medical operable",
"criterion": "medical operability",
"requirements": [
{
"requirement_type": "status",
"expected_value": "operable"
}
]
},
{
"exact_snippets": "surgical resectable",
"criterion": "surgical resectability",
"requirements": [
{
"requirement_type": "status",
"expected_value": "resectable"
}
]
},
{
"exact_snippets": "cT1, cT2 selected cT3",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"cT1",
"cT2",
"selected cT3"
]
}
]
},
{
"exact_snippets": "intraparenchymal tumour >7cm",
"criterion": "intraparenchymal tumor size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 7,
"unit": "cm"
}
}
]
},
{
"exact_snippets": "T3 chest wall",
"criterion": "T3 chest wall involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "T3 based on additional nodule in the lobe of the primary tumour",
"criterion": "T3 additional nodule in the lobe of the primary tumor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "cN1 based on CT or PET",
"criterion": "cN1 nodal involvement",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": [
"CT",
"PET"
]
}
]
},
{
"exact_snippets": "18 years or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "Informed Consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "status",
"expected_value": "obtained"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 90 Years",
"criterions": [
{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "History of mediastinoscopy No integrated FDG PET/CT available No videomediastinoscopy available EBUS/EUS for mediastinal staging of present N1 disease cN2: mediastinal nodes enlarged on CT or Pet positive invasion of mediastinal pleura invasion of phrenic nerve invasion of parietal pericardium tumour in main bronchus less than 2cm form the main carina cT4 cM1 former therapy for lung cancer (chemotherapy, radiotherapy, surgery) technical contraindication for videomediastinoscopy ( eg extreme kyphosis, cutaneous tracheostomy, extreme goiter) pregnancy inability to consent",
"criterions": [
{
"exact_snippets": "History of mediastinoscopy",
"criterion": "history of mediastinoscopy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "No integrated FDG PET/CT available",
"criterion": "integrated FDG PET/CT availability",
"requirements": [
{
"requirement_type": "availability",
"expected_value": false
}
]
},
{
"exact_snippets": "No videomediastinoscopy available",
"criterion": "videomediastinoscopy availability",
"requirements": [
{
"requirement_type": "availability",
"expected_value": false
}
]
},
{
"exact_snippets": "EBUS/EUS for mediastinal staging of present N1 disease",
"criterion": "EBUS/EUS for mediastinal staging",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "cN2: mediastinal nodes enlarged on CT or Pet positive",
"criterion": "cN2 mediastinal nodes",
"requirements": [
{
"requirement_type": "enlargement",
"expected_value": true
}
]
},
{
"exact_snippets": "invasion of mediastinal pleura",
"criterion": "invasion of mediastinal pleura",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "invasion of phrenic nerve",
"criterion": "invasion of phrenic nerve",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "invasion of parietal pericardium",
"criterion": "invasion of parietal pericardium",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "tumour in main bronchus less than 2cm form the main carina",
"criterion": "tumour in main bronchus proximity to main carina",
"requirements": [
{
"requirement_type": "distance",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "cm"
}
}
]
},
{
"exact_snippets": "cT4",
"criterion": "cT4",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "cM1",
"criterion": "cM1",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "former therapy for lung cancer (chemotherapy, radiotherapy, surgery)",
"criterion": "former therapy for lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "technical contraindication for videomediastinoscopy ( eg extreme kyphosis, cutaneous tracheostomy, extreme goiter)",
"criterion": "technical contraindication for videomediastinoscopy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "inability to consent",
"criterion": "inability to consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}