{
"info": {
"nct_id": "NCT05405673",
"official_title": "A Prospective Cross-sectional Multi-center Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia",
"inclusion_criteria": "1. They require elective colonoscopy for colorectal cancer screening or polyp surveillance, or investigation of symptoms (e.g. anemia, change of bowel habit, abdominal pain);\n2. Aged ≥18 years old;\n3. Written informed consent obtained.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);\n2. Contraindication to polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);\n3. Known colorectal cancer or adenoma for staged procedure;\n4. Previous colonic resection;\n5. Personal history of colorectal cancer;\n6. Personal history of polyposis syndrome;\n7. Personal history of inflammatory bowel disease;\n8. Known pregnancy or lactation;\n9. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. They require elective colonoscopy for colorectal cancer screening or polyp surveillance, or investigation of symptoms (e.g. anemia, change of bowel habit, abdominal pain);",
"criterions": [
{
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"criterion": "elective colonoscopy",
"requirement": {
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}
},
{
"exact_snippets": "elective colonoscopy for ... polyp surveillance",
"criterion": "elective colonoscopy",
"requirement": {
"requirement_type": "purpose",
"expected_value": "polyp surveillance"
}
},
{
"exact_snippets": "elective colonoscopy for ... investigation of symptoms",
"criterion": "elective colonoscopy",
"requirement": {
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"expected_value": "investigation of symptoms"
}
},
{
"exact_snippets": "symptoms (e.g. anemia",
"criterion": "symptoms",
"requirement": {
"requirement_type": "examples",
"expected_value": [
"anemia"
]
}
},
{
"exact_snippets": "symptoms ... change of bowel habit",
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]
}
},
{
"exact_snippets": "symptoms ... abdominal pain",
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]
}
}
]
},
"logical_structure": {
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{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "elective colonoscopy for colorectal cancer screening",
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"requirement_type": "purpose",
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}
}
]
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{
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"exact_snippets": "elective colonoscopy for ... polyp surveillance",
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}
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]
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{
"and_criteria": [
{
"exact_snippets": "elective colonoscopy for ... investigation of symptoms",
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{
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]
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}
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},
{
"identified_line": {
"line": "2. Aged ≥18 years old;",
"criterions": [
{
"exact_snippets": "Aged ≥18 years old",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "Aged ≥18 years old",
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"expected_value": {
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"value": 18,
"unit": "years"
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{
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"line": "3. Written informed consent obtained.",
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"expected_value": true
}
}
]
},
"logical_structure": {
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"expected_value": true
}
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]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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}
}
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"logical_structure": {
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"value": 18,
"unit": "Years"
}
}
}
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],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);",
"criterions": [
{
"exact_snippets": "Contraindications to colonoscopy (e.g. perforation",
"criterion": "perforation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Contraindications to colonoscopy (e.g. ... intestinal obstruction",
"criterion": "intestinal obstruction",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "Contraindications to colonoscopy (e.g. ... unstable cardiopulmonary status",
"criterion": "unstable cardiopulmonary status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "Contraindications to colonoscopy (e.g. perforation",
"criterion": "perforation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Contraindications to colonoscopy (e.g. ... intestinal obstruction",
"criterion": "intestinal obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Contraindications to colonoscopy (e.g. ... unstable cardiopulmonary status",
"criterion": "unstable cardiopulmonary status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "2. Contraindication to polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);",
"criterions": [
{
"exact_snippets": "Contraindication to polyp resection",
"criterion": "contraindication to polyp resection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "active gastrointestinal bleeding",
"criterion": "active gastrointestinal bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "uninterrupted anticoagulation",
"criterion": "uninterrupted anticoagulation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "dual antiplatelets",
"criterion": "dual antiplatelets",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Contraindication to polyp resection",
"criterion": "contraindication to polyp resection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "active gastrointestinal bleeding",
"criterion": "active gastrointestinal bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "uninterrupted anticoagulation",
"criterion": "uninterrupted anticoagulation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "dual antiplatelets",
"criterion": "dual antiplatelets",
"requirement": {
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"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "3. Known colorectal cancer or adenoma for staged procedure;",
"criterions": [
{
"exact_snippets": "Known colorectal cancer",
"criterion": "colorectal cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "adenoma for staged procedure",
"criterion": "adenoma",
"requirement": {
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"expected_value": "staged"
}
}
]
},
"logical_structure": {
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"criterion": "colorectal cancer",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "adenoma for staged procedure",
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"expected_value": "staged"
}
}
]
}
},
{
"identified_line": {
"line": "4. Previous colonic resection;",
"criterions": [
{
"exact_snippets": "Previous colonic resection",
"criterion": "colonic resection",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previous colonic resection",
"criterion": "colonic resection",
"requirement": {
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}
}
}
},
{
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"requirement": {
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}
}
]
},
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"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
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"criterions": [
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"exact_snippets": "Personal history of polyposis syndrome",
"criterion": "polyposis syndrome",
"requirement": {
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"expected_value": true
}
}
]
},
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}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "7. Personal history of inflammatory bowel disease;",
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{
"exact_snippets": "Personal history of inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
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"expected_value": true
}
}
]
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{
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"expected_value": false
}
},
{
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"requirement": {
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}
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{
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"criterion": "comorbid conditions",
"requirement": {
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"operator": ">=",
"value": 4,
"unit": "ASA grade"
}
}
}
]
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}
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],
"failed_miscellaneous": []
}