{
"info": {
"nct_id": "NCT02466113",
"official_title": "A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Chemotherapy of Stage II Colon Cancer Based on a 6 microRNA Stratified Tool",
"inclusion_criteria": "* The informed consent has been obtained from the patient.\n* With confirmed diagnosis of stage II colon cancer.\n* With moderate/good ECOG health rating (PS): 0-1 score.\n* The patient receive no anti-cancer treatment before primary surgery.\n* The patient receive radical operation for colon cancer with negative margin.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.\n* With bad compliance or contraindication to enrollment.\n* Pregnant woman or lactating woman.\n* With contraindication to receive adjuvant chemotherapy.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* The informed consent has been obtained from the patient.",
"criterions": [
{
"exact_snippets": [
"The informed consent has been obtained from the patient"
],
"criterion": "informed consent",
"requirement_type": "obtained",
"expected_value": true
}
]
},
{
"line": "* With confirmed diagnosis of stage II colon cancer.",
"criterions": [
{
"exact_snippets": [
"confirmed diagnosis of stage II colon cancer"
],
"criterion": "colon cancer",
"requirement_type": "stage",
"expected_value": "II"
}
]
},
{
"line": "* With moderate/good ECOG health rating (PS): 0-1 score.",
"criterions": [
{
"exact_snippets": [
"ECOG health rating",
"0-1 score"
],
"criterion": "ECOG health rating",
"requirement_type": "score",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0
},
{
"operator": "<=",
"value": 1
}
]
}
}
]
},
{
"line": "* The patient receive no anti-cancer treatment before primary surgery.",
"criterions": [
{
"exact_snippets": [
"no anti-cancer treatment before primary surgery"
],
"criterion": "anti-cancer treatment",
"requirement_type": "prior to primary surgery",
"expected_value": false
}
]
},
{
"line": "* The patient receive radical operation for colon cancer with negative margin.",
"criterions": [
{
"exact_snippets": [
"radical operation for colon cancer"
],
"criterion": "colon cancer operation",
"requirement_type": "type",
"expected_value": "radical"
},
{
"exact_snippets": [
"negative margin"
],
"criterion": "surgical margin",
"requirement_type": "status",
"expected_value": "negative"
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "volunteer health status",
"requirement_type": "allowed",
"expected_value": true
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
{
"line": "Must have maximum age of 65 Years",
"criterions": [
{
"exact_snippets": [
"maximum age of 65 Years"
],
"criterion": "age",
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 65
}
}
]
}
],
"exclusion_lines": [
{
"line": "* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.",
"criterions": [
{
"exact_snippets": [
"severe comorbidities",
"cardiovascular disease"
],
"criterion": "cardiovascular disease",
"requirement_type": "severity",
"expected_value": "severe"
},
{
"exact_snippets": [
"severe comorbidities",
"chronic obstructive pulmonary disease"
],
"criterion": "chronic obstructive pulmonary disease",
"requirement_type": "severity",
"expected_value": "severe"
},
{
"exact_snippets": [
"severe comorbidities",
"diabetes mellitus"
],
"criterion": "diabetes mellitus",
"requirement_type": "severity",
"expected_value": "severe"
},
{
"exact_snippets": [
"severe comorbidities",
"chronic renal dysfunction"
],
"criterion": "chronic renal dysfunction",
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"line": "* With bad compliance or contraindication to enrollment.",
"criterions": [
{
"exact_snippets": [
"bad compliance"
],
"criterion": "compliance",
"requirement_type": "quality",
"expected_value": "bad"
},
{
"exact_snippets": [
"contraindication to enrollment"
],
"criterion": "contraindication",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* Pregnant woman or lactating woman.",
"criterions": [
{
"exact_snippets": [
"Pregnant woman"
],
"criterion": "pregnancy",
"requirement_type": "status",
"expected_value": true
},
{
"exact_snippets": [
"lactating woman"
],
"criterion": "lactation",
"requirement_type": "status",
"expected_value": true
}
]
},
{
"line": "* With contraindication to receive adjuvant chemotherapy.",
"criterions": [
{
"exact_snippets": [
"contraindication to receive adjuvant chemotherapy"
],
"criterion": "adjuvant chemotherapy",
"requirement_type": "contraindication",
"expected_value": true
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}