{
"info": {
"nct_id": "NCT05802420",
"official_title": "The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer",
"inclusion_criteria": "* patients with histologically confirmed unresectable advanced or metastatic pancreatic cancer;\n* both sexes, age ≥18 years old;\n* ECOG performance status score ≤2;\n* the expected survival time was ≥3 months.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;\n* treated with any systemic antitumor treatment before first-line chemotherapy onset;\n* died or lost to follow-up within one month after the initiation of first-line chemotherpay;\n* combined with other primary malignances.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* patients with histologically confirmed unresectable advanced or metastatic pancreatic cancer;",
"criterions": [
{
"exact_snippets": "histologically confirmed",
"criterion": "histological confirmation",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
}
]
},
{
"exact_snippets": "unresectable",
"criterion": "resectability of pancreatic cancer",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": false
}
]
},
{
"exact_snippets": "advanced or metastatic pancreatic cancer",
"criterion": "stage of pancreatic cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"advanced",
"metastatic"
]
}
]
}
]
},
{
"line": "* both sexes, age ≥18 years old;",
"criterions": [
{
"exact_snippets": "both sexes",
"criterion": "sex",
"requirements": [
{
"requirement_type": "allowed",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "age ≥18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* ECOG performance status score ≤2;",
"criterions": [
{
"exact_snippets": "ECOG performance status score ≤2",
"criterion": "ECOG performance status score",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* the expected survival time was ≥3 months.",
"criterions": [
{
"exact_snippets": "expected survival time was ≥3 months",
"criterion": "expected survival time",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;",
"criterions": [
{
"exact_snippets": "a known diagnosis of pancreatic cancer other than ductal adenocarcinoma",
"criterion": "pancreatic cancer diagnosis",
"requirements": [
{
"requirement_type": "type",
"expected_value": "other than ductal adenocarcinoma"
}
]
}
]
},
{
"line": "* treated with any systemic antitumor treatment before first-line chemotherapy onset;",
"criterions": [
{
"exact_snippets": "treated with any systemic antitumor treatment before first-line chemotherapy onset",
"criterion": "prior systemic antitumor treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* combined with other primary malignances.",
"criterions": [
{
"exact_snippets": "combined with other primary malignances",
"criterion": "primary malignancies",
"requirements": [
{
"requirement_type": "combination",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* died or lost to follow-up within one month after the initiation of first-line chemotherpay;",
"criterions": [
{
"exact_snippets": "died ... within one month after the initiation of first-line chemotherapy",
"criterion": "mortality",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within one month after the initiation of first-line chemotherapy"
}
]
},
{
"exact_snippets": "lost to follow-up within one month after the initiation of first-line chemotherapy",
"criterion": "follow-up status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "lost"
},
{
"requirement_type": "time frame",
"expected_value": "within one month after the initiation of first-line chemotherapy"
}
]
}
]
}
],
"failed_miscellaneous": []
}