[96a5a0]: / output / allTrials / logical / NCT00560365_logical.json

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{
"info": {
"nct_id": "NCT00560365",
"official_title": "A Randomised Controlled Trial to Assess the Cost-effectiveness of Intensive Versus no Scheduled Follow-up in Patients Who Have Undergone Resection for Colorectal Cancer With Curative Intent. (FACS - Follow-up After Colorectal Surgery)",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 50 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of primary colorectal cancer\n\n * Stage I-III disease\n* Have undergone curative resection (i.e., no residual disease [R0])\n\n * Microscopically clear margins\n* Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy\n* Post-operative blood CEA ≤ 10 ng/mL (if the normal range is ≤ 5 ng/mL) OR < 2 times upper limit of normal (if normal range is > 5 ng/mL)\n\n * For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy\n* Has completed primary curative treatment, as deemed by hospital clinician\n\n * Patients awaiting stoma closure allowed\n* No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray)\n* No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer\n\nPATIENT CHARACTERISTICS:\n\n* No concurrent serious illness\n* History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved\n* No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 50 Years",
"criterions": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Diagnosis of primary colorectal cancer",
"criterions": [
{
"exact_snippets": "Diagnosis of primary colorectal cancer",
"criterion": "primary colorectal cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis of primary colorectal cancer",
"criterion": "primary colorectal cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Stage I-III disease",
"criterions": [
{
"exact_snippets": "Stage I-III disease",
"criterion": "disease stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "Stage"
},
{
"operator": "<=",
"value": 3,
"unit": "Stage"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Stage I-III disease",
"criterion": "disease stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "Stage"
},
{
"operator": "<=",
"value": 3,
"unit": "Stage"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Have undergone curative resection (i.e., no residual disease [R0])",
"criterions": [
{
"exact_snippets": "Have undergone curative resection",
"criterion": "curative resection",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "no residual disease [R0]",
"criterion": "residual disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Have undergone curative resection",
"criterion": "curative resection",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "no residual disease [R0]",
"criterion": "residual disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Microscopically clear margins",
"criterions": [
{
"exact_snippets": "Microscopically clear margins",
"criterion": "surgical margins",
"requirement": {
"requirement_type": "microscopic clarity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Microscopically clear margins",
"criterion": "surgical margins",
"requirement": {
"requirement_type": "microscopic clarity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy",
"criterions": [
{
"exact_snippets": "patients undergoing adjuvant therapy",
"criterion": "adjuvant therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "CEA should be measured",
"criterion": "CEA measurement",
"requirement": {
"requirement_type": "timing",
"expected_value": "after completion of chemotherapy"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "patients undergoing adjuvant therapy",
"criterion": "adjuvant therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "CEA should be measured",
"criterion": "CEA measurement",
"requirement": {
"requirement_type": "timing",
"expected_value": "after completion of chemotherapy"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Has completed primary curative treatment, as deemed by hospital clinician",
"criterions": [
{
"exact_snippets": "Has completed primary curative treatment",
"criterion": "primary curative treatment",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Has completed primary curative treatment",
"criterion": "primary curative treatment",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients awaiting stoma closure allowed",
"criterions": [
{
"exact_snippets": "Patients awaiting stoma closure",
"criterion": "stoma closure",
"requirement": {
"requirement_type": "status",
"expected_value": "awaiting"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients awaiting stoma closure",
"criterion": "stoma closure",
"requirement": {
"requirement_type": "status",
"expected_value": "awaiting"
}
}
]
}
},
{
"identified_line": {
"line": "* No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray)",
"criterions": [
{
"exact_snippets": "No evidence of metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pre- or post-operative liver CT scan (or ultrasound)",
"criterion": "liver imaging",
"requirement": {
"requirement_type": "type",
"expected_value": [
"CT scan",
"ultrasound"
]
}
},
{
"exact_snippets": "chest CT scan (or chest x-ray)",
"criterion": "chest imaging",
"requirement": {
"requirement_type": "type",
"expected_value": [
"CT scan",
"x-ray"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No evidence of metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pre- or post-operative liver CT scan (or ultrasound)",
"criterion": "liver imaging",
"requirement": {
"requirement_type": "type",
"expected_value": [
"CT scan",
"ultrasound"
]
}
}
]
},
{
"exact_snippets": "chest CT scan (or chest x-ray)",
"criterion": "chest imaging",
"requirement": {
"requirement_type": "type",
"expected_value": [
"CT scan",
"x-ray"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer",
"criterions": [
{
"exact_snippets": "No diagnosis of familial adenomatous polyposis (FAP)",
"criterion": "familial adenomatous polyposis (FAP)",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": false
}
},
{
"exact_snippets": "No diagnosis of ... dominantly inherited colon cancer",
"criterion": "dominantly inherited colon cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No diagnosis of familial adenomatous polyposis (FAP)",
"criterion": "familial adenomatous polyposis (FAP)",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": false
}
},
{
"exact_snippets": "No diagnosis of ... dominantly inherited colon cancer",
"criterion": "dominantly inherited colon cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up",
"criterions": [
{
"exact_snippets": "History of other carcinoma allowed",
"criterion": "history of other carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "primary treatment has been completed",
"criterion": "primary treatment completion",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "no evidence of recurrent disease",
"criterion": "recurrent disease",
"requirement": {
"requirement_type": "evidence",
"expected_value": false
}
},
{
"exact_snippets": "no follow-up that conflicts with study follow-up",
"criterion": "conflicting follow-up",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "History of other carcinoma allowed",
"criterion": "history of other carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "primary treatment has been completed",
"criterion": "primary treatment completion",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "no evidence of recurrent disease",
"criterion": "recurrent disease",
"requirement": {
"requirement_type": "evidence",
"expected_value": false
}
},
{
"exact_snippets": "no follow-up that conflicts with study follow-up",
"criterion": "conflicting follow-up",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "refer to disease characteristics section"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "refer to disease characteristics section"
}
}
]
}
},
{
"identified_line": {
"line": "* Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved",
"criterions": [
{
"exact_snippets": "Pre-operative radiotherapy ... allowed",
"criterion": "pre-operative radiotherapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
},
{
"exact_snippets": "Pre-operative ... chemoradiotherapy ... allowed",
"criterion": "pre-operative chemoradiotherapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
},
{
"exact_snippets": "curative resection has been achieved",
"criterion": "curative resection",
"requirement": {
"requirement_type": "achievement",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"or_criteria": [
{
"exact_snippets": "Pre-operative radiotherapy ... allowed",
"criterion": "pre-operative radiotherapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
},
{
"exact_snippets": "Pre-operative ... chemoradiotherapy ... allowed",
"criterion": "pre-operative chemoradiotherapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
}
]
},
"then_criteria": {
"exact_snippets": "curative resection has been achieved",
"criterion": "curative resection",
"requirement": {
"requirement_type": "achievement",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements",
"criterions": [
{
"exact_snippets": "No concurrent participation in a primary treatment clinical trial",
"criterion": "concurrent participation in a primary treatment clinical trial",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
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"and_criteria": [
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{
"identified_line": {
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"and_criteria": []
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"failed_exclusion": [],
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]
}