[96a5a0]: / output / allTrials / identified / NCT06673472_identified.json

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{
"info": {
"nct_id": "NCT06673472",
"official_title": "Comparison of Long-term Outcomes Between Upfront Surgery and Neoadjuvant Therapy Followed by Surgery in Patients with Node-Negative Gastric Cancer: a Propensity Score Matched International Multicenter Study",
"inclusion_criteria": "(1) preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) underwent radical gastrectomy (R0) and D2 lymphadenectomy; (5) postoperative pathology confirmed no lymph node metastasis (i.e., lymph node-negative); and (6) follow-up for at least 3 years.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "(1) considered early-stage gastric cancer before surgery; (2) distant metastasis detected preoperatively or intraoperatively; (3) failure to achieve R0 resection and D2 lymphadenectomy during surgery; (4) concurrent diagnosis of other malignancies; (5) remnant gastric cancer; (6) death within 30 days postoperatively; and (7) incomplete baseline data or follow-up records.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "(1) preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) underwent radical gastrectomy (R0) and D2 lymphadenectomy; (5) postoperative pathology confirmed no lymph node metastasis (i.e., lymph node-negative); and (6) follow-up for at least 3 years.",
"criterions": [
{
"exact_snippets": "preoperative clinical staging of cT2-4NxM0",
"criterion": "clinical staging",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "cT2-4NxM0"
}
]
},
{
"exact_snippets": "primary gastric adenocarcinoma confirmed via pathology",
"criterion": "gastric adenocarcinoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "pathology"
}
]
},
{
"exact_snippets": "no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT",
"criterion": "distant metastasis",
"requirements": [
{
"requirement_type": "absence",
"expected_value": true
},
{
"requirement_type": "confirmation",
"expected_value": [
"preoperative chest X-ray",
"chest CT",
"abdominal ultrasound",
"abdominal CT"
]
}
]
},
{
"exact_snippets": "underwent radical gastrectomy (R0) and D2 lymphadenectomy",
"criterion": "surgical procedure",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"radical gastrectomy (R0)",
"D2 lymphadenectomy"
]
}
]
},
{
"exact_snippets": "postoperative pathology confirmed no lymph node metastasis (i.e., lymph node-negative)",
"criterion": "lymph node metastasis",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "postoperative pathology"
},
{
"requirement_type": "status",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "follow-up for at least 3 years",
"criterion": "follow-up duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"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 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 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "(1) considered early-stage gastric cancer before surgery; (2) distant metastasis detected preoperatively or intraoperatively; (3) failure to achieve R0 resection and D2 lymphadenectomy during surgery; (4) concurrent diagnosis of other malignancies; (5) remnant gastric cancer; (6) death within 30 days postoperatively; and (7) incomplete baseline data or follow-up records.",
"criterions": [
{
"exact_snippets": "considered early-stage gastric cancer before surgery",
"criterion": "early-stage gastric cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "early-stage"
}
]
},
{
"exact_snippets": "distant metastasis detected preoperatively or intraoperatively",
"criterion": "distant metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "failure to achieve R0 resection and D2 lymphadenectomy during surgery",
"criterion": "R0 resection",
"requirements": [
{
"requirement_type": "achievement",
"expected_value": false
}
]
},
{
"exact_snippets": "failure to achieve R0 resection and D2 lymphadenectomy during surgery",
"criterion": "D2 lymphadenectomy",
"requirements": [
{
"requirement_type": "achievement",
"expected_value": false
}
]
},
{
"exact_snippets": "concurrent diagnosis of other malignancies",
"criterion": "other malignancies",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "remnant gastric cancer",
"criterion": "remnant gastric cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "death within 30 days postoperatively",
"criterion": "death",
"requirements": [
{
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
]
},
{
"exact_snippets": "incomplete baseline data or follow-up records",
"criterion": "baseline data",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": false
}
]
},
{
"exact_snippets": "incomplete baseline data or follow-up records",
"criterion": "follow-up records",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}