{
"info": {
"nct_id": "NCT03837782",
"official_title": "Minimally Invasive Versus Abdominal Radical Resection for Colorectal Cancer",
"inclusion_criteria": "(i) tumor without distant metastasis; (ii) classified as stage I, II or III by TNM staging system; (iii) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; (iv) a minimum of 12 lymph nodes resected to accurately identify stage; (v) solitary malignant lesion after thorough colonoscopy; (vi) complete resection (R0) with no positive nodes left behind; (vii) histological diagnosis of adenocarcinoma.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "(i) <18 years or >90 years; (ii) serious concurrent illness; (iii) clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT); (iv) familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal cancer (HNPCC) and other hereditary CRC; (v) postoperative pathological close, indeterminate, or positive margins; (vi) circumferential resection margin < 1mm in rectal cancer; (vii) short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "(i) tumor without distant metastasis; (ii) classified as stage I, II or III by TNM staging system; (iii) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; (iv) a minimum of 12 lymph nodes resected to accurately identify stage; (v) solitary malignant lesion after thorough colonoscopy; (vi) complete resection (R0) with no positive nodes left behind; (vii) histological diagnosis of adenocarcinoma.",
"criterions": [
{
"exact_snippets": "tumor without distant metastasis",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "classified as stage I, II or III by TNM staging system",
"criterion": "TNM stage",
"requirement": {
"requirement_type": "classification",
"expected_value": [
"I",
"II",
"III"
]
}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": "=",
"value": 0,
"unit": "N/A"
},
{
"operator": "=",
"value": 1,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "a minimum of 12 lymph nodes resected",
"criterion": "lymph nodes resected",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "N/A"
}
}
},
{
"exact_snippets": "solitary malignant lesion after thorough colonoscopy",
"criterion": "solitary malignant lesion",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "complete resection (R0) with no positive nodes left behind",
"criterion": "complete resection (R0)",
"requirement": {
"requirement_type": "status",
"expected_value": "R0"
}
},
{
"exact_snippets": "histological diagnosis of adenocarcinoma",
"criterion": "histological diagnosis",
"requirement": {
"requirement_type": "type",
"expected_value": "adenocarcinoma"
}
}
]
},
"logical_structure": {
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"exact_snippets": "tumor without distant metastasis",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "classified as stage I, II or III by TNM staging system",
"criterion": "TNM stage",
"requirement": {
"requirement_type": "classification",
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"I",
"II",
"III"
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}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
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"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": "=",
"value": 0,
"unit": "N/A"
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{
"operator": "=",
"value": 1,
"unit": "N/A"
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},
{
"exact_snippets": "a minimum of 12 lymph nodes resected",
"criterion": "lymph nodes resected",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "N/A"
}
}
},
{
"exact_snippets": "solitary malignant lesion after thorough colonoscopy",
"criterion": "solitary malignant lesion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "complete resection (R0) with no positive nodes left behind",
"criterion": "complete resection (R0)",
"requirement": {
"requirement_type": "status",
"expected_value": "R0"
}
},
{
"exact_snippets": "histological diagnosis of adenocarcinoma",
"criterion": "histological diagnosis",
"requirement": {
"requirement_type": "type",
"expected_value": "adenocarcinoma"
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 90 Years",
"criterions": [
{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 90,
"unit": "Years"
}
}
}
]
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}
],
"exclusion_lines": [
{
"identified_line": {
"line": "(i) <18 years or >90 years; (ii) serious concurrent illness; (iii) clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT); (iv) familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal cancer (HNPCC) and other hereditary CRC; (v) postoperative pathological close, indeterminate, or positive margins; (vi) circumferential resection margin < 1mm in rectal cancer; (vii) short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency.",
"criterions": [
{
"exact_snippets": "<18 years or >90 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18,
"unit": "years"
},
{
"operator": ">",
"value": 90,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "serious concurrent illness",
"criterion": "concurrent illness",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT)",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "detection method",
"expected_value": "PET-CT"
}
},
{
"exact_snippets": "clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT)",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "clinical suspicion",
"expected_value": true
}
},
{
"exact_snippets": "familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal cancer (HNPCC) and other hereditary CRC",
"criterion": "hereditary colorectal cancer syndromes",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"familial adenomatous polyposis syndrome (FAP)",
"hereditary non-polyposis colorectal cancer (HNPCC)",
"other hereditary CRC"
]
}
},
{
"exact_snippets": "postoperative pathological close, indeterminate, or positive margins",
"criterion": "postoperative pathological margins",
"requirement": {
"requirement_type": "status",
"expected_value": [
"close",
"indeterminate",
"positive"
]
}
},
{
"exact_snippets": "circumferential resection margin < 1mm in rectal cancer",
"criterion": "circumferential resection margin",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "mm"
}
}
},
{
"exact_snippets": "short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": "short"
}
},
{
"exact_snippets": "short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "cause",
"expected_value": "postoperative comorbidities due to cardiopulmonary insufficiency"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "<18 years or >90 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
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{
"operator": "<",
"value": 18,
"unit": "years"
},
{
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"unit": "years"
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}
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},
{
"and_criteria": [
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"exact_snippets": "serious concurrent illness",
"criterion": "concurrent illness",
"requirement": {
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"expected_value": "serious"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT)",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "detection method",
"expected_value": "PET-CT"
}
},
{
"exact_snippets": "clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT)",
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"requirement": {
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"expected_value": true
}
}
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{
"and_criteria": [
{
"exact_snippets": "familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal cancer (HNPCC) and other hereditary CRC",
"criterion": "hereditary colorectal cancer syndromes",
"requirement": {
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"familial adenomatous polyposis syndrome (FAP)",
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]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "postoperative pathological close, indeterminate, or positive margins",
"criterion": "postoperative pathological margins",
"requirement": {
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]
}
}
]
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{
"and_criteria": [
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"exact_snippets": "circumferential resection margin < 1mm in rectal cancer",
"criterion": "circumferential resection margin",
"requirement": {
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"operator": "<",
"value": 1,
"unit": "mm"
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}
}
]
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{
"and_criteria": [
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"exact_snippets": "short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency",
"criterion": "life expectancy",
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}
},
{
"exact_snippets": "short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency",
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}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
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"requirement": {
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"expected_value": "healthy"
}
}
]
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},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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"failed_exclusion": [],
"failed_miscellaneous": []
}