{
    "info": {
        "nct_id": "NCT00001148",
        "official_title": "Detection of Glioblastoma or Anaplastic Astrocytoma Cells in the Circulation During Surgical Resection",
        "inclusion_criteria": "Healthy volunteers allowed",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "INCLUSION CRITERIA:\n\nPatients must be diagnosed with biopsy-proven glioblastoma multiforme or anaplastic astrocytoma (WHO grade III and IV, WHO classification of glial tumors) and meet the following criteria:\n\nConsenting males and females between the ages of 18 and 75, inclusive.\n\nProvided written informed consent prior to participation in the trial.\n\nKarnofsky Performance Scale Score greater than or equal to 60.\n\nPatients of all races and sexes are eligible for this study. Children and adolescents only rarely are afflicted with gliomas that are amenable for surgical resection, and so are excluded from this study.\n\nPatients who have been accepted for glioma resection under existing NINDS protocols are also eligible for this study.\n\nIf tumor tissue is available from biopsy prior to surgery, we will attempt to identify tumor-specific mutation(s) prior to enrolling the patient.\n\nEXCLUSION CRITERIA:\n\nClinically unstable condition.\n\nLiver function impairment (total bilirubin greater than 2.0 mg/dl; AST or ALT greater than 3 times the upper limit of normal).\n\nCoagulopathy (prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times control).\n\nThrombocytopenia (platelet count less than 100,000/mm3).\n\nGranulocytopenia (absolute neutrophil count less than 1,000/mm3).\n\nAcute infection.\n\nAcute medical problems.\n\nPositive HIV test.\n\nKarnofsky Performance Scale Score less than 60.\n\nAllergy to CT contrast agents.\n\nAbsence of tumor-specific gene mutation.\n\nPregnant women. Women of child-bearing potential will undergo a urine and/or serum pregnancy test. Women who are pregnant will not be allowed to participate in this study."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "Patients must be diagnosed with biopsy-proven glioblastoma multiforme or anaplastic astrocytoma (WHO grade III and IV, WHO classification of glial tumors) and meet the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with biopsy-proven glioblastoma multiforme",
                    "criterion": "glioblastoma multiforme",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed with biopsy-proven ... anaplastic astrocytoma",
                    "criterion": "anaplastic astrocytoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "WHO grade III and IV, WHO classification of glial tumors",
                    "criterion": "WHO grade",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Consenting males and females between the ages of 18 and 75, inclusive.",
            "criterions": [
                {
                    "exact_snippets": "Consenting males and females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "between the ages of 18 and 75, inclusive",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Provided written informed consent prior to participation in the trial.",
            "criterions": [
                {
                    "exact_snippets": "written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Karnofsky Performance Scale Score greater than or equal to 60.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Scale Score greater than or equal to 60",
                    "criterion": "Karnofsky Performance Scale Score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients of all races and sexes are eligible for this study. Children and adolescents only rarely are afflicted with gliomas that are amenable for surgical resection, and so are excluded from this study.",
            "criterions": [
                {
                    "exact_snippets": "Patients of all races",
                    "criterion": "race",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "all ... sexes",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Children and adolescents ... are excluded from this study",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients who have been accepted for glioma resection under existing NINDS protocols are also eligible for this study.",
            "criterions": [
                {
                    "exact_snippets": "accepted for glioma resection under existing NINDS protocols",
                    "criterion": "acceptance for glioma resection",
                    "requirements": [
                        {
                            "requirement_type": "protocol",
                            "expected_value": "existing NINDS protocols"
                        }
                    ]
                }
            ]
        },
        {
            "line": "If tumor tissue is available from biopsy prior to surgery, we will attempt to identify tumor-specific mutation(s) prior to enrolling the patient.",
            "criterions": [
                {
                    "exact_snippets": "tumor tissue is available from biopsy",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "identify tumor-specific mutation(s)",
                    "criterion": "tumor-specific mutation(s)",
                    "requirements": [
                        {
                            "requirement_type": "identification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Clinically unstable condition.",
            "criterions": [
                {
                    "exact_snippets": "Clinically unstable condition.",
                    "criterion": "clinical stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Liver function impairment (total bilirubin greater than 2.0 mg/dl; AST or ALT greater than 3 times the upper limit of normal).",
            "criterions": [
                {
                    "exact_snippets": "Liver function impairment (total bilirubin greater than 2.0 mg/dl",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver function impairment ... AST or ALT greater than 3 times the upper limit of normal",
                    "criterion": "AST or ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "greater than 3 times the upper limit of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Coagulopathy (prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times control).",
            "criterions": [
                {
                    "exact_snippets": "Coagulopathy (prothrombin time [PT] ... > 1.5 times control)",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times control"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Coagulopathy ... activated partial thromboplastin time [APTT] > 1.5 times control",
                    "criterion": "activated partial thromboplastin time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times control"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Thrombocytopenia (platelet count less than 100,000/mm3).",
            "criterions": [
                {
                    "exact_snippets": "Thrombocytopenia (platelet count less than 100,000/mm3)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Granulocytopenia (absolute neutrophil count less than 1,000/mm3).",
            "criterions": [
                {
                    "exact_snippets": "Granulocytopenia (absolute neutrophil count less than 1,000/mm3)",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Acute infection.",
            "criterions": [
                {
                    "exact_snippets": "Acute infection",
                    "criterion": "acute infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Acute medical problems.",
            "criterions": [
                {
                    "exact_snippets": "Acute medical problems",
                    "criterion": "acute medical problems",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Positive HIV test.",
            "criterions": [
                {
                    "exact_snippets": "Positive HIV test",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Karnofsky Performance Scale Score less than 60.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Scale Score less than 60",
                    "criterion": "Karnofsky Performance Scale Score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Allergy to CT contrast agents.",
            "criterions": [
                {
                    "exact_snippets": "Allergy to CT contrast agents.",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "CT contrast agents"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Absence of tumor-specific gene mutation.",
            "criterions": [
                {
                    "exact_snippets": "Absence of tumor-specific gene mutation.",
                    "criterion": "tumor-specific gene mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "Pregnant women. Women of child-bearing potential will undergo a urine and/or serum pregnancy test. Women who are pregnant will not be allowed to participate in this study.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women. Women who are pregnant will not be allowed to participate",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "urine and/or serum pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "urine",
                                "serum"
                            ]
                        }
                    ]
                }
            ]
        }
    ]
}