{
    "info": {
        "nct_id": "NCT02704520",
        "official_title": "Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker to Stratify Management of Good and Poor Responders to Radiotherapy: A Rectal Cancer Multicentre Randomised Control Trial to Avoid Surgery With 'Watch and Wait' or Intensify Treatment According to mrTRG",
        "inclusion_criteria": "1. MRI defined locally advanced rectal carcinoma i.e. one or more: greater than or equal to mrT3c; mrEMVI positive; mr N1c; mr CRM positive\n2. Biopsy confirmed adenocarcinoma of radiologically defined rectum\n3. Be deemed to require preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT)\nHealthy volunteers allowed\nMust have minimum age of 16 Years",
        "exclusion_criteria": "1. Metastatic disease\n2. MRI, radiotherapy and/or chemotherapy contraindications\n3. A post-treatment MRI performed more than 10 weeks after the completion of radiotherapy if given\n4. Previous malignancy within preceding 5 years if risk of recurrence >5%",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. MRI defined locally advanced rectal carcinoma i.e. one or more: greater than or equal to mrT3c; mrEMVI positive; mr N1c; mr CRM positive",
            "criterions": [
                {
                    "exact_snippets": "MRI defined locally advanced rectal carcinoma",
                    "criterion": "locally advanced rectal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "MRI defined"
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than or equal to mrT3c",
                    "criterion": "mrT stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": ">= mrT3c"
                        }
                    ]
                },
                {
                    "exact_snippets": "mrEMVI positive",
                    "criterion": "mrEMVI",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "mr N1c",
                    "criterion": "mrN stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "mrN1c"
                        }
                    ]
                },
                {
                    "exact_snippets": "mr CRM positive",
                    "criterion": "mrCRM",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Biopsy confirmed adenocarcinoma of radiologically defined rectum",
            "criterions": [
                {
                    "exact_snippets": "Biopsy confirmed adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "radiologically defined rectum",
                    "criterion": "rectum",
                    "requirements": [
                        {
                            "requirement_type": "definition method",
                            "expected_value": "radiologically"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Be deemed to require preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT)",
            "criterions": [
                {
                    "exact_snippets": "require preoperative chemoradiotherapy (CRT)",
                    "criterion": "preoperative chemoradiotherapy (CRT)",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "require ... total neoadjuvant therapy (TNT)",
                    "criterion": "total neoadjuvant therapy (TNT)",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "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 16 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 16 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. MRI, radiotherapy and/or chemotherapy contraindications",
            "criterions": [
                {
                    "exact_snippets": "MRI ... contraindications",
                    "criterion": "MRI",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy ... contraindications",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy contraindications",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. A post-treatment MRI performed more than 10 weeks after the completion of radiotherapy if given",
            "criterions": [
                {
                    "exact_snippets": "post-treatment MRI performed",
                    "criterion": "post-treatment MRI",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "completion of radiotherapy if given",
                    "criterion": "completion of radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Previous malignancy within preceding 5 years if risk of recurrence >5%",
            "criterions": [
                {
                    "exact_snippets": "Previous malignancy within preceding 5 years",
                    "criterion": "previous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "risk of recurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}