{
"info": {
"nct_id": "NCT06381882",
"official_title": "Establishing the Role of the Human Microbiome in Patients With a Presumed Pancreatic or Periampullary (Pre)Malignancy and Pancreatic Resection.",
"inclusion_criteria": "* Adult patient with a resectable, borderline resectable or locally advanced pancreatic and periampullary presumed (pre)malignancy.\n* The intention of the treatment must be curative including surgery and (neo-)adjuvant chemotherapy.\n* Willing and able to adhere to the study procedures described in this protocol and to grant the study team access to the electronic patient file and other data that are required to answer the research questions described in this protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Inability to provide adequate informed consent (e.g. language barrier, illiteracy)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Adult patient with a resectable, borderline resectable or locally advanced pancreatic and periampullary presumed (pre)malignancy.",
"criterions": [
{
"exact_snippets": "Adult patient",
"criterion": "age",
"requirements": [
{
"requirement_type": "age group",
"expected_value": "adult"
}
]
},
{
"exact_snippets": "resectable, borderline resectable or locally advanced pancreatic and periampullary presumed (pre)malignancy",
"criterion": "pancreatic and periampullary malignancy",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": [
"resectable",
"borderline resectable",
"locally advanced"
]
}
]
}
]
},
{
"line": "* The intention of the treatment must be curative including surgery and (neo-)adjuvant chemotherapy.",
"criterions": [
{
"exact_snippets": "intention of the treatment must be curative",
"criterion": "treatment intention",
"requirements": [
{
"requirement_type": "intention",
"expected_value": "curative"
}
]
},
{
"exact_snippets": "including surgery",
"criterion": "treatment type",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": "surgery"
}
]
},
{
"exact_snippets": "(neo-)adjuvant chemotherapy",
"criterion": "treatment type",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": "(neo-)adjuvant chemotherapy"
}
]
}
]
},
{
"line": "* Willing and able to adhere to the study procedures described in this protocol and to grant the study team access to the electronic patient file and other data that are required to answer the research questions described in this protocol.",
"criterions": [
{
"exact_snippets": "Willing and able to adhere to the study procedures",
"criterion": "adherence to study procedures",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "grant the study team access to the electronic patient file and other data",
"criterion": "access to patient data",
"requirements": [
{
"requirement_type": "permission",
"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": "* Inability to provide adequate informed consent (e.g. language barrier, illiteracy)",
"criterions": [
{
"exact_snippets": "Inability to provide adequate informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "language barrier",
"criterion": "language barrier",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "illiteracy",
"criterion": "illiteracy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}