{
"info": {
"nct_id": "NCT02476682",
"official_title": "Evaluation of Stool and Blood Based Tests for Colorectal Advanced Mucosal Neoplasia",
"inclusion_criteria": "* Individuals capable and willing of proving satisfactory informed consent\n* Individuals with colonic lesions larger than 20mm\n* Individuals diagnosed with laterally spreading or sessile polyp morphology\n* Individuals schedules for screening colonoscopy and with no prior history of CRC\n* Ability and willingness to collect stool sample at home\n* Ability and willingness to undergo venepuncture procedure\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Individuals not able or unwilling to provide informed consent\n* Individuals less than 18 year of age\n* Individuals who undergo an incomplete colonoscopy or resection, which raises doubt as to the status of the colon (post-hoc exclusion)\n* Individuals with a prior history of CRC\n* Individuals with a history of Irritable Bowel Disease (IBD), hereditary nonpolyposis colorectal cancer (HNPCC) or Familial adenomatous polyposis (FAP)\n* Individuals with bleeding diathesis\n* Pregnancy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Individuals capable and willing of proving satisfactory informed consent",
"criterions": [
{
"exact_snippets": "capable and willing of proving satisfactory informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "capability",
"expected_value": true
},
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Individuals with colonic lesions larger than 20mm",
"criterions": [
{
"exact_snippets": "colonic lesions larger than 20mm",
"criterion": "colonic lesions",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 20,
"unit": "mm"
}
}
]
}
]
},
{
"line": "* Individuals diagnosed with laterally spreading or sessile polyp morphology",
"criterions": [
{
"exact_snippets": "diagnosed with laterally spreading ... polyp morphology",
"criterion": "laterally spreading polyp morphology",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "diagnosed with ... sessile polyp morphology",
"criterion": "sessile polyp morphology",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Individuals schedules for screening colonoscopy and with no prior history of CRC",
"criterions": [
{
"exact_snippets": "Individuals schedules for screening colonoscopy",
"criterion": "screening colonoscopy",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": true
}
]
},
{
"exact_snippets": "no prior history of CRC",
"criterion": "prior history of CRC",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Ability and willingness to collect stool sample at home",
"criterions": [
{
"exact_snippets": "Ability and willingness to collect stool sample at home",
"criterion": "stool sample collection",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
},
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Ability and willingness to undergo venepuncture procedure",
"criterions": [
{
"exact_snippets": "Ability ... to undergo venepuncture procedure",
"criterion": "venepuncture procedure",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "willingness to undergo venepuncture procedure",
"criterion": "venepuncture procedure",
"requirements": [
{
"requirement_type": "willingness",
"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": "* Individuals not able or unwilling to provide informed consent",
"criterions": [
{
"exact_snippets": "not able ... to provide informed consent",
"criterion": "ability to provide informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "not ... willing to provide informed consent",
"criterion": "willingness to provide informed consent",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Individuals less than 18 year of age",
"criterions": [
{
"exact_snippets": "less than 18 year of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "year"
}
}
]
}
]
},
{
"line": "* Individuals who undergo an incomplete colonoscopy or resection, which raises doubt as to the status of the colon (post-hoc exclusion)",
"criterions": [
{
"exact_snippets": "undergo an incomplete colonoscopy",
"criterion": "colonoscopy",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": false
}
]
},
{
"exact_snippets": "undergo an incomplete ... resection",
"criterion": "resection",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": false
}
]
}
]
},
{
"line": "* Individuals with a prior history of CRC",
"criterions": [
{
"exact_snippets": "prior history of CRC",
"criterion": "CRC (Colorectal Cancer)",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Individuals with a history of Irritable Bowel Disease (IBD), hereditary nonpolyposis colorectal cancer (HNPCC) or Familial adenomatous polyposis (FAP)",
"criterions": [
{
"exact_snippets": "history of Irritable Bowel Disease (IBD)",
"criterion": "Irritable Bowel Disease (IBD)",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "history of ... hereditary nonpolyposis colorectal cancer (HNPCC)",
"criterion": "hereditary nonpolyposis colorectal cancer (HNPCC)",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "history of ... Familial adenomatous polyposis (FAP)",
"criterion": "Familial adenomatous polyposis (FAP)",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Individuals with bleeding diathesis",
"criterions": [
{
"exact_snippets": "bleeding diathesis",
"criterion": "bleeding diathesis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnancy",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}