{
    "info": {
        "nct_id": "NCT01882660",
        "official_title": "Pre-operative Decitabine in Colon Cancer: a Proof of Principle Study",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "In- and exclusion criteria first part:\n\nIn order to participate in the first part of the study, five extra fresh biopsies to determine tumor methylation status, a subject must meet all of the following criteria:\n\nInclusion criteria:\n\n1. Biopsy proven colon cancer or high suspicion of colon cancer on a previous endoscopy.\n2. Planned endoscopy.\n3. Age ≥ 18yr.\n4. ECOG/ WHO performance 0-2.\n5. Written informed consent.\n\nExclusion criteria:\n\n1. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.\n\nIn- and exclusion criteria second part:\n\nIn order to participate in the second part of the study - treatment with decitabine - a subject must meet all of the following criteria:\n\nInclusion criteriä:\n\n1. Patients with biopsy proven colon cancer who will undergo primary tumor resection.\n2. Age ≥ 18yr.\n3. ECOG/ WHO performance 0-2.\n4. Adequate bone marrow function (ANC>1500/mm3, hemoglobin>9g/dL (which may be obtained by transfusions), platelets>100,000)\n5. Adequate hepatic function (AST and ALT <2.5x upper limit of normal (ULN)).\n6. Adequate renal function (Serum creatinine ≤1.5 x ULN or calculated creatinine of >50ml/min)\n7. Women of child-bearing age must be willing to use adequate contraception and have negative serum or urine pregnancy test within 3 days prior to registration.\n8. Written informed consent.\n\nExclusion criteria:\n\n1. Known hypersensitivity to decitabine or its additives.\n2. Surgery not planned according to time frame of the study,\n3. Other systemic or local treatment of the primary tumor in the waiting time until surgery.\n4. Administration of any experimental drug within 60 days prior to the first dose of decitabine."
    },
    "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 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": [],
    "miscellaneous_lines": [
        {
            "line": "In order to participate in the first part of the study, five extra fresh biopsies to determine tumor methylation status, a subject must meet all of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "five extra fresh biopsies",
                    "criterion": "biopsies",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "biopsies"
                            }
                        },
                        {
                            "requirement_type": "freshness",
                            "expected_value": "fresh"
                        }
                    ]
                },
                {
                    "exact_snippets": "determine tumor methylation status",
                    "criterion": "tumor methylation status",
                    "requirements": [
                        {
                            "requirement_type": "determinability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Biopsy proven colon cancer or high suspicion of colon cancer on a previous endoscopy.",
            "criterions": [
                {
                    "exact_snippets": "Biopsy proven colon cancer",
                    "criterion": "colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "high suspicion of colon cancer on a previous endoscopy",
                    "criterion": "colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "suspicion level",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "endoscopy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Planned endoscopy.",
            "criterions": [
                {
                    "exact_snippets": "Planned endoscopy",
                    "criterion": "endoscopy",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Age ≥ 18yr.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18yr.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "yr"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ECOG/ WHO performance 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG/ WHO performance 0-2",
                    "criterion": "ECOG/WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "psychological ... condition potentially hampering adequate informed consent or compliance with the study protocol",
                    "criterion": "psychological condition",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "potentially hampering adequate informed consent or compliance with the study protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "familial ... condition potentially hampering adequate informed consent or compliance with the study protocol",
                    "criterion": "familial condition",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "potentially hampering adequate informed consent or compliance with the study protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "sociological ... condition potentially hampering adequate informed consent or compliance with the study protocol",
                    "criterion": "sociological condition",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "potentially hampering adequate informed consent or compliance with the study protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical condition potentially hampering adequate informed consent or compliance with the study protocol",
                    "criterion": "geographical condition",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "potentially hampering adequate informed consent or compliance with the study protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "In order to participate in the second part of the study - treatment with decitabine - a subject must meet all of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "treatment with decitabine",
                    "criterion": "treatment with decitabine",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Patients with biopsy proven colon cancer who will undergo primary tumor resection.",
            "criterions": [
                {
                    "exact_snippets": "biopsy proven colon cancer",
                    "criterion": "colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "will undergo primary tumor resection",
                    "criterion": "primary tumor resection",
                    "requirements": [
                        {
                            "requirement_type": "planned procedure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age ≥ 18yr.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18yr.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "yr"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG/ WHO performance 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG/ WHO performance 0-2",
                    "criterion": "ECOG/WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Adequate bone marrow function (ANC>1500/mm3, hemoglobin>9g/dL (which may be obtained by transfusions), platelets>100,000)",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function (ANC>1500/mm3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function ... hemoglobin>9g/dL (which may be obtained by transfusions)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function ... platelets>100,000",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Adequate hepatic function (AST and ALT <2.5x upper limit of normal (ULN)).",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... <2.5x upper limit of normal (ULN)",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT <2.5x upper limit of normal (ULN)",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate renal function (Serum creatinine ≤1.5 x ULN or calculated creatinine of >50ml/min)",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function (Serum creatinine ≤1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine of >50ml/min",
                    "criterion": "calculated creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Women of child-bearing age must be willing to use adequate contraception and have negative serum or urine pregnancy test within 3 days prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum or urine pregnancy test within 3 days prior to registration",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 3 days prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Known hypersensitivity to decitabine or its additives.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to decitabine",
                    "criterion": "hypersensitivity to decitabine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... its additives",
                    "criterion": "hypersensitivity to decitabine additives",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Surgery not planned according to time frame of the study,",
            "criterions": [
                {
                    "exact_snippets": "Surgery not planned according to time frame of the study",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Other systemic or local treatment of the primary tumor in the waiting time until surgery.",
            "criterions": [
                {
                    "exact_snippets": "Other systemic or local treatment of the primary tumor",
                    "criterion": "treatment of the primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "systemic",
                                "local"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Administration of any experimental drug within 60 days prior to the first dose of decitabine.",
            "criterions": [
                {
                    "exact_snippets": "Administration of any experimental drug within 60 days prior to the first dose of decitabine.",
                    "criterion": "experimental drug administration",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "In- and exclusion criteria first part:",
            "criterions": []
        },
        {
            "line": "Inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        },
        {
            "line": "In- and exclusion criteria second part:",
            "criterions": []
        },
        {
            "line": "Inclusion criteriä:",
            "criterions": []
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        }
    ]
}