{
    "info": {
        "nct_id": "NCT00846482",
        "official_title": "Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer",
        "inclusion_criteria": "* Histologically confirmed diagnosis of colorectal cancer.\n* ECOG Performance Status 0-2 (Appendix A).\n* Patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting.\n* Consent to donate 4 tubes of PBMC of 7 ml of blood each.\n* Willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria).\n* Adequate organ function as defined as:\n\n  * Neutrophil count > 1500/μl\n  * Platelets > 75,000/ μl\n  * Hemoglobin > 8 g/dl\n  * Bilirubin < 2.0 X upper limit of normal\n  * Creatinine < 2 mg% or calculated clearance > 40 ml/mt\n* The patient must have signed a consent form approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB\nHealthy volunteers allowed",
        "exclusion_criteria": "* No other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment.\n* Pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study.\n* Patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery).\n* Patients with grade 2 neuropathy will not be eligible for the study.\n* The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas. At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed diagnosis of colorectal cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status 0-2 (Appendix A).",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status 0-2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting.",
            "criterions": [
                {
                    "exact_snippets": "Patient is a candidate for oxaliplatin based therapy",
                    "criterion": "oxaliplatin based therapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "either in the adjuvant or in the metastatic setting",
                    "criterion": "treatment setting",
                    "requirements": [
                        {
                            "requirement_type": "setting",
                            "expected_value": [
                                "adjuvant",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Consent to donate 4 tubes of PBMC of 7 ml of blood each.",
            "criterions": [
                {
                    "exact_snippets": "Consent to donate 4 tubes of PBMC of 7 ml of blood each.",
                    "criterion": "donation of PBMC",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "tubes"
                            }
                        },
                        {
                            "requirement_type": "volume per tube",
                            "expected_value": {
                                "operator": "=",
                                "value": 7,
                                "unit": "ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria).",
            "criterions": [
                {
                    "exact_snippets": "Willing to consider additional post therapy tumor biopsy",
                    "criterion": "willingness to consider post therapy tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function as defined as:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophil count > 1500/μl",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil count > 1500/μl",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "μl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets > 75,000/ μl",
            "criterions": [
                {
                    "exact_snippets": "Platelets > 75,000/ μl",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 75000,
                                "unit": "/ μl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin > 8 g/dl",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 8 g/dl",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin < 2.0 X upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin < 2.0 X upper limit of normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "X upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine < 2 mg% or calculated clearance > 40 ml/mt",
            "criterions": [
                {
                    "exact_snippets": "Creatinine < 2 mg%",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "mg%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated clearance > 40 ml/mt",
                    "criterion": "calculated clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "ml/mt"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must have signed a consent form approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB",
            "criterions": [
                {
                    "exact_snippets": "The patient must have signed a consent form",
                    "criterion": "consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB",
                    "criterion": "approval",
                    "requirements": [
                        {
                            "requirement_type": "approved by",
                            "expected_value": [
                                "Albert Einstein College of Medicine Cancer Center CCI",
                                "Montefiore Medical Center IRB"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* No other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment.",
            "criterions": [
                {
                    "exact_snippets": "No other significant underlying medical condition",
                    "criterion": "underlying medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant hepatic ... requiring active medical treatment",
                    "criterion": "hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "active medical treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant ... bone marrow ... requiring active medical treatment",
                    "criterion": "bone marrow disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "active medical treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant ... cardiac disease, requiring active medical treatment",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "active medical treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of child bearing potential not practicing birth control",
                    "criterion": "birth control practice",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active males unwilling to practice contraception",
                    "criterion": "contraception practice",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery).",
            "criterions": [
                {
                    "exact_snippets": "Patients undergoing major surgical procedures",
                    "criterion": "major surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "delayed enrollment until complete recovery from their surgery - 4 wk for major",
                    "criterion": "recovery time from major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "wk"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "delayed enrollment until complete recovery from their surgery ... 2 wk from minor surgery",
                    "criterion": "recovery time from minor surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "wk"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with grade 2 neuropathy will not be eligible for the study.",
            "criterions": [
                {
                    "exact_snippets": "grade 2 neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas. At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment.",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas.",
                    "criterion": "prior therapy with mitomycin C or nitrosoureas",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.",
                    "criterion": "prior palliative radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}