{
"info": {
"nct_id": "NCT05604573",
"official_title": "DNA Mutation Detection in Circulating Tumor DNA and Tissue by Massive Multiplex Allele Discrimination Priming System(mmADPS) for Pancreatic Cancer",
"inclusion_criteria": "* Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins\n* Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule\n* Among patients diagnosed with benign pancreatic diseases (pancreatic cyst, chronic pancreatitis, etc.), patients who have need for histological examination as control group\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form\n* If a laboratory test is impossible due to a qualitative problem with the collected blood sample\n* Where the collected tissue does not contain tissue of the desired malignant or benign disease",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins",
"criterions": [
{
"exact_snippets": "diagnosed with pancreatic cancer",
"criterion": "pancreatic cancer diagnosis",
"requirements": [
{
"requirement_type": "method",
"expected_value": [
"histological",
"radiologic"
]
}
]
},
{
"exact_snippets": "before treatment begins",
"criterion": "treatment status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "before treatment"
}
]
}
]
},
{
"line": "* Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule",
"criterions": [
{
"exact_snippets": "Patients aged 18 or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "voluntarily agrees to participate",
"criterion": "voluntary participation",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": true
}
]
},
{
"exact_snippets": "willing to understand and comply with the subsequent treatment procedures",
"criterion": "compliance with treatment procedures",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "willing to ... comply with the ... sample collection schedule",
"criterion": "compliance with sample collection schedule",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Among patients diagnosed with benign pancreatic diseases (pancreatic cyst, chronic pancreatitis, etc.), patients who have need for histological examination as control group",
"criterions": [
{
"exact_snippets": "diagnosed with benign pancreatic diseases",
"criterion": "benign pancreatic diseases",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "need for histological examination",
"criterion": "need for histological examination",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"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": "* Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form",
"criterions": [
{
"exact_snippets": "subject himself/herself refuses to fill out the consent form",
"criterion": "consent form completion",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "unable to fill out the consent form",
"criterion": "consent form completion",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* If a laboratory test is impossible due to a qualitative problem with the collected blood sample",
"criterions": [
{
"exact_snippets": "a laboratory test is impossible due to a qualitative problem with the collected blood sample",
"criterion": "blood sample",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "sufficient for laboratory test"
}
]
}
]
},
{
"line": "* Where the collected tissue does not contain tissue of the desired malignant or benign disease",
"criterions": [
{
"exact_snippets": "collected tissue does not contain tissue of the desired malignant or benign disease",
"criterion": "collected tissue",
"requirements": [
{
"requirement_type": "content",
"expected_value": "desired malignant or benign disease"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}