{
    "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": [
        {
            "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 50 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 50 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Diagnosis of primary colorectal cancer",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of primary colorectal cancer",
                    "criterion": "primary colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage I-III disease",
            "criterions": [
                {
                    "exact_snippets": "Stage I-III disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "Stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "Stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have undergone curative resection (i.e., no residual disease [R0])",
            "criterions": [
                {
                    "exact_snippets": "Have undergone curative resection",
                    "criterion": "curative resection",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no residual disease [R0]",
                    "criterion": "residual disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Microscopically clear margins",
            "criterions": [
                {
                    "exact_snippets": "Microscopically clear margins",
                    "criterion": "surgical margins",
                    "requirements": [
                        {
                            "requirement_type": "microscopic clarity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "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",
                    "criterion": "colonic imaging",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": "complete"
                        },
                        {
                            "requirement_type": "normality",
                            "expected_value": "normal"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "pre-operatively",
                                "post-operatively"
                            ]
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "colonoscopy",
                                "barium enema",
                                "CT pneumocolon",
                                "virtual colonoscopy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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)",
            "criterions": [
                {
                    "exact_snippets": "Post-operative blood CEA ≤ 10 ng/mL",
                    "criterion": "post-operative blood CEA",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Post-operative blood CEA ... < 2 times upper limit of normal",
                    "criterion": "post-operative blood CEA",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "patients undergoing adjuvant therapy",
                    "criterion": "adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CEA should be measured",
                    "criterion": "CEA measurement",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after completion of chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has completed primary curative treatment, as deemed by hospital clinician",
            "criterions": [
                {
                    "exact_snippets": "Has completed primary curative treatment",
                    "criterion": "primary curative treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients awaiting stoma closure allowed",
            "criterions": [
                {
                    "exact_snippets": "Patients awaiting stoma closure",
                    "criterion": "stoma closure",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "awaiting"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pre- or post-operative liver CT scan (or ultrasound)",
                    "criterion": "liver imaging",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "CT scan",
                                "ultrasound"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "chest CT scan (or chest x-ray)",
                    "criterion": "chest imaging",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "CT scan",
                                "x-ray"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No diagnosis of ... dominantly inherited colon cancer",
                    "criterion": "dominantly inherited colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent serious illness",
            "criterions": [
                {
                    "exact_snippets": "No concurrent serious illness",
                    "criterion": "serious illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary treatment has been completed",
                    "criterion": "primary treatment completion",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of recurrent disease",
                    "criterion": "recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no follow-up that conflicts with study follow-up",
                    "criterion": "conflicting follow-up",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "refer to disease characteristics section"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pre-operative ... chemoradiotherapy ... allowed",
                    "criterion": "pre-operative chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curative resection has been achieved",
                    "criterion": "curative resection",
                    "requirements": [
                        {
                            "requirement_type": "achievement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "conflicting follow-up requirements",
                    "criterion": "conflicting follow-up requirements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}