{
"info": {
"nct_id": "NCT05444491",
"official_title": "Based on the Application of Peripheral Blood Polygene Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer",
"inclusion_criteria": "1. Newly diagnosed patients with primary colorectal cancer confirmed by histopathology (no restriction on histological type);\n2. Patients diagnosed as stage I-III and feasible for radical bowel surgery;\n3. Patients diagnosed by stage IV (only colorectal cancer patients with liver metastasis at the time of diagnosis) and feasible radical bowel resection or complete resection of liver metastasis;\n4. No gender limitation, age ≥18;\n5. ECOG score ≤1;\n6. Life expectancy ≥5 years;\n7. Those who fully understand the study and voluntarily sign the informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Blood transfusion was performed during surgery or 2 weeks before surgery;\n2. complicated with primary malignant tumors of other organs;\n3. With colonic obstruction, intestinal perforation and other symptoms requiring emergency treatment;\n4. Colorectal cancer was diagnosed with extrahepatic metastasis;\n5. Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowel resection;\n6. Radical bowel resection was performed after endoscopic surgery;\n7. Concomitant symptoms and/or family history collection suggest hereditary colorectal cancer;\n8. serious mental illness or drug abuse;\n9. patients with serious heart, lung and vascular diseases who cannot tolerate surgery;\n10. pregnant or lactating women;\n11. Participate in other interventional clinical investigators within 3 months\n12. Poor compliance, unable to complete the study according to the judgment of the researcher.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Newly diagnosed patients with primary colorectal cancer confirmed by histopathology (no restriction on histological type);",
"criterions": [
{
"exact_snippets": "Newly diagnosed patients",
"criterion": "diagnosis status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "newly diagnosed"
}
]
},
{
"exact_snippets": "primary colorectal cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "primary colorectal cancer"
}
]
},
{
"exact_snippets": "confirmed by histopathology",
"criterion": "confirmation method",
"requirements": [
{
"requirement_type": "method",
"expected_value": "histopathology"
}
]
}
]
},
{
"line": "2. Patients diagnosed as stage I-III and feasible for radical bowel surgery;",
"criterions": [
{
"exact_snippets": "Patients diagnosed as stage I-III",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
},
{
"exact_snippets": "feasible for radical bowel surgery",
"criterion": "feasibility for radical bowel surgery",
"requirements": [
{
"requirement_type": "feasibility",
"expected_value": true
}
]
}
]
},
{
"line": "3. Patients diagnosed by stage IV (only colorectal cancer patients with liver metastasis at the time of diagnosis) and feasible radical bowel resection or complete resection of liver metastasis;",
"criterions": [
{
"exact_snippets": "Patients diagnosed by stage IV (only colorectal cancer patients with liver metastasis at the time of diagnosis)",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "IV"
}
]
},
{
"exact_snippets": "colorectal cancer patients",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "colorectal"
}
]
},
{
"exact_snippets": "liver metastasis at the time of diagnosis",
"criterion": "liver metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "feasible radical bowel resection",
"criterion": "radical bowel resection",
"requirements": [
{
"requirement_type": "feasibility",
"expected_value": true
}
]
},
{
"exact_snippets": "complete resection of liver metastasis",
"criterion": "liver metastasis resection",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": true
}
]
}
]
},
{
"line": "4. No gender limitation, age ≥18;",
"criterions": [
{
"exact_snippets": "No gender limitation",
"criterion": "gender",
"requirements": [
{
"requirement_type": "limitation",
"expected_value": false
}
]
},
{
"exact_snippets": "age ≥18",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "5. ECOG score ≤1;",
"criterions": [
{
"exact_snippets": "ECOG score ≤1",
"criterion": "ECOG score",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "6. Life expectancy ≥5 years;",
"criterions": [
{
"exact_snippets": "Life expectancy ≥5 years;",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "years"
}
}
]
}
]
},
{
"line": "7. Those who fully understand the study and voluntarily sign the informed consent.",
"criterions": [
{
"exact_snippets": "fully understand the study",
"criterion": "understanding of the study",
"requirements": [
{
"requirement_type": "comprehension",
"expected_value": true
}
]
},
{
"exact_snippets": "voluntarily sign the informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"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": "1. Blood transfusion was performed during surgery or 2 weeks before surgery;",
"criterions": [
{
"exact_snippets": "Blood transfusion was performed during surgery",
"criterion": "blood transfusion",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "during surgery"
}
]
},
{
"exact_snippets": "Blood transfusion was performed ... 2 weeks before surgery",
"criterion": "blood transfusion",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "2 weeks before surgery"
}
]
}
]
},
{
"line": "2. complicated with primary malignant tumors of other organs;",
"criterions": [
{
"exact_snippets": "complicated with primary malignant tumors of other organs",
"criterion": "primary malignant tumors of other organs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "3. With colonic obstruction, intestinal perforation and other symptoms requiring emergency treatment;",
"criterions": [
{
"exact_snippets": "colonic obstruction",
"criterion": "colonic obstruction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "intestinal perforation",
"criterion": "intestinal perforation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "other symptoms requiring emergency treatment",
"criterion": "symptoms requiring emergency treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "4. Colorectal cancer was diagnosed with extrahepatic metastasis;",
"criterions": [
{
"exact_snippets": "Colorectal cancer was diagnosed",
"criterion": "colorectal cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "extrahepatic metastasis",
"criterion": "extrahepatic metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "5. Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowel resection;",
"criterions": [
{
"exact_snippets": "Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowel resection",
"criterion": "neoadjuvant therapy",
"requirements": [
{
"requirement_type": "types",
"expected_value": [
"radiotherapy",
"chemotherapy"
]
},
{
"requirement_type": "timing",
"expected_value": "before radical bowel resection"
}
]
}
]
},
{
"line": "6. Radical bowel resection was performed after endoscopic surgery;",
"criterions": [
{
"exact_snippets": "Radical bowel resection was performed",
"criterion": "radical bowel resection",
"requirements": [
{
"requirement_type": "performed",
"expected_value": true
}
]
},
{
"exact_snippets": "after endoscopic surgery",
"criterion": "endoscopic surgery",
"requirements": [
{
"requirement_type": "performed",
"expected_value": true
}
]
}
]
},
{
"line": "7. Concomitant symptoms and/or family history collection suggest hereditary colorectal cancer;",
"criterions": [
{
"exact_snippets": "Concomitant symptoms and/or family history collection suggest hereditary colorectal cancer",
"criterion": "hereditary colorectal cancer",
"requirements": [
{
"requirement_type": "suggestion",
"expected_value": true
}
]
}
]
},
{
"line": "8. serious mental illness or drug abuse;",
"criterions": [
{
"exact_snippets": "serious mental illness",
"criterion": "mental illness",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
},
{
"exact_snippets": "drug abuse",
"criterion": "drug abuse",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "9. patients with serious heart, lung and vascular diseases who cannot tolerate surgery;",
"criterions": [
{
"exact_snippets": "serious heart ... diseases",
"criterion": "heart disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
},
{
"exact_snippets": "serious ... lung ... diseases",
"criterion": "lung disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
},
{
"exact_snippets": "serious ... vascular diseases",
"criterion": "vascular disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
},
{
"exact_snippets": "cannot tolerate surgery",
"criterion": "surgical tolerance",
"requirements": [
{
"requirement_type": "tolerance",
"expected_value": false
}
]
}
]
},
{
"line": "10. pregnant or lactating women;",
"criterions": [
{
"exact_snippets": "pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "11. Participate in other interventional clinical investigators within 3 months",
"criterions": [
{
"exact_snippets": "Participate in other interventional clinical investigators within 3 months",
"criterion": "participation in other interventional clinical trials",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "12. Poor compliance, unable to complete the study according to the judgment of the researcher.",
"criterions": [
{
"exact_snippets": "Poor compliance",
"criterion": "compliance",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "poor"
}
]
},
{
"exact_snippets": "unable to complete the study",
"criterion": "ability to complete the study",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}