{
    "info": {
        "nct_id": "NCT01479894",
        "official_title": "Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer",
        "inclusion_criteria": "* Subjects must be 18 years of age or older.\n* Subjects must be AA or Caucasian.\n* Subjects with pathologic stage II colon cancer; Irrespective of number of nodes examined.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients of races other than AA or Caucasian.\n* No tumor block available from initial diagnosis.\n* No tumor or very little tumor (<5% tumor present) in block as assessed by examination of the H&E slide by the Genomic Health, Inc (GHI) - designated pathologist.\n* Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by the GHI-designated pathologist.\n* Insufficient RNA (<5 ng/μL or 300 ng) for RT-PCR (radiation therapy - pathologic complete response) analysis.\n* Failure of assay to meet pre-specified quality control (QC) specifications.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects must be 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must be 18 years of age or older.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must be AA or Caucasian.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must be AA or Caucasian.",
                    "criterion": "race",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "AA",
                                "Caucasian"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with pathologic stage II colon cancer; Irrespective of number of nodes examined.",
            "criterions": [
                {
                    "exact_snippets": "pathologic stage II colon cancer",
                    "criterion": "colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "II"
                        },
                        {
                            "requirement_type": "pathologic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Irrespective of number of nodes examined",
                    "criterion": "number of nodes examined",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "Irrespective"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients of races other than AA or Caucasian.",
            "criterions": [
                {
                    "exact_snippets": "races other than AA or Caucasian",
                    "criterion": "race",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "AA",
                                "Caucasian"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No tumor block available from initial diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "No tumor block available",
                    "criterion": "tumor block",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No tumor or very little tumor (<5% tumor present) in block as assessed by examination of the H&E slide by the Genomic Health, Inc (GHI) - designated pathologist.",
            "criterions": [
                {
                    "exact_snippets": "No tumor or very little tumor (<5% tumor present)",
                    "criterion": "tumor presence",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "examination of the H&E slide by the Genomic Health, Inc (GHI) - designated pathologist",
                    "criterion": "H&E slide examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by the GHI-designated pathologist.",
            "criterions": [
                {
                    "exact_snippets": "Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "adenocarcinoma NOS",
                                "mucinous carcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "as assessed by examination of the H&E slide by the GHI-designated pathologist",
                    "criterion": "pathologist assessment",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "examination of the H&E slide by the GHI-designated pathologist"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Insufficient RNA (<5 ng/μL or 300 ng) for RT-PCR (radiation therapy - pathologic complete response) analysis.",
            "criterions": [
                {
                    "exact_snippets": "Insufficient RNA (<5 ng/μL or 300 ng) for RT-PCR",
                    "criterion": "RNA concentration",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "ng/μL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 300,
                                        "unit": "ng"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failure of assay to meet pre-specified quality control (QC) specifications.",
            "criterions": [
                {
                    "exact_snippets": "Failure of assay to meet pre-specified quality control (QC) specifications.",
                    "criterion": "assay quality control",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": "pre-specified QC specifications"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}