{
    "info": {
        "nct_id": "NCT00939666",
        "official_title": "Minimal Invasive Treatment for Patients With Good Response to Chemoradiation With Selection and Follow-up by MRI: a Single Arm Phase-II Feasibility Study in Rectal Cancer",
        "inclusion_criteria": "* 18 years or older\n* Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response: Clinical complete response (ycT0N0) or very good response (ycT1-2N0) after pre-operative chemoradiation will be determined clinically (digital rectal examination, endoscopy), radiologically (contrast-enhanced-MRI) and pathologically (biopsy)\n* Informed consent and capability of giving informed consent\n* Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient (in other words that the patient understands the experimental base of the study).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Recurrent rectal cancer.\n* Distant metastasis.\n* Unable or unwilling to comply to the intensive follow-up schedule.\n* Contra-indications for MRI. If MRI is not possible because of contra-indications (e.g. pacemaker) we will exclude patients. MRI is crucial for response evaluation and follow-up and can not be omitted in patients that follow the alternative strategies ('wait-and-see policy' or TEM).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent and capability of giving informed consent",
            "criterions": [
                {
                    "exact_snippets": "Informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "capability of giving informed consent",
                    "criterion": "capability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient (in other words that the patient understands the experimental base of the study).",
            "criterions": [
                {
                    "exact_snippets": "Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient",
                    "criterion": "comprehension of alternative strategies and unknown risks",
                    "requirements": [
                        {
                            "requirement_type": "clarity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patient understands the experimental base of the study",
                    "criterion": "understanding of experimental base",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "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": "* Recurrent rectal cancer.",
            "criterions": [
                {
                    "exact_snippets": "Recurrent rectal cancer.",
                    "criterion": "rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Distant metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable or unwilling to comply to the intensive follow-up schedule.",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to comply to the intensive follow-up schedule.",
                    "criterion": "compliance to follow-up schedule",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contra-indications for MRI. If MRI is not possible because of contra-indications (e.g. pacemaker) we will exclude patients. MRI is crucial for response evaluation and follow-up and can not be omitted in patients that follow the alternative strategies ('wait-and-see policy' or TEM).",
            "criterions": [
                {
                    "exact_snippets": "Contra-indications for MRI",
                    "criterion": "MRI contra-indications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pacemaker",
                    "criterion": "pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response: Clinical complete response (ycT0N0) or very good response (ycT1-2N0) after pre-operative chemoradiation will be determined clinically (digital rectal examination, endoscopy), radiologically (contrast-enhanced-MRI) and pathologically (biopsy)",
            "criterions": [
                {
                    "exact_snippets": "primary rectal cancer",
                    "criterion": "primary rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "underwent CRT",
                    "criterion": "chemoradiation therapy (CRT)",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical complete response (ycT0N0)",
                    "criterion": "clinical complete response",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ycT0N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "very good response (ycT1-2N0)",
                    "criterion": "very good response",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ycT1-2N0"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}