{
    "info": {
        "nct_id": "NCT01146366",
        "official_title": "Utility of Routine Cervical Mediastinoscopy in Clinically Staged T2N0M0 and Select T1N0M0 Non-Small Cell Lung Cancers by FDG-PET and CT Scans",
        "inclusion_criteria": "1. Patients must have proven or suspected clinical stage I NSCLC. Clinical stage IA (T1N0M0) patients are only allowed participation if the maxSUV of the primary tumor is >/=10. Clinical stage IB (T2N0M0) must be by size criterion only (i.e. the tumor must be > 3cm in size. Patients that have T2 tumors by visceral pleural involvement only are not eligible for the study).\n2. Patients must be surgical candidates for at least a lobectomy or other anatomical resection (via either video-assisted thoracoscopic surgery, or open approach).\n3. Patient must have an ECOG/Zubrod score of 0, 1 or 2.\n4. Patients must not have undergone previous invasive mediastinal staging for this cancer.\n5. Patients must not have a tracheostomy.\n6. Patient must have a CT of the chest and upper abdomen or an FDG-PET scan performed within 60 days of enrollment to the study that confirms their clinical stage I status. Both scans must be performed, only one needs to be within 60 days of enrollment to the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "There are no separately noted exclusion criteria. All criteria are listed under inclusion.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients must have proven or suspected clinical stage I NSCLC. Clinical stage IA (T1N0M0) patients are only allowed participation if the maxSUV of the primary tumor is >/=10. Clinical stage IB (T2N0M0) must be by size criterion only (i.e. the tumor must be > 3cm in size. Patients that have T2 tumors by visceral pleural involvement only are not eligible for the study).",
            "criterions": [
                {
                    "exact_snippets": "proven or suspected clinical stage I NSCLC",
                    "criterion": "clinical stage I NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stage IA (T1N0M0) ... maxSUV of the primary tumor is >/=10",
                    "criterion": "maxSUV of the primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stage IB (T2N0M0) ... by size criterion only ... tumor must be > 3cm in size",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "T2 tumors by visceral pleural involvement only are not eligible",
                    "criterion": "T2 tumors by visceral pleural involvement",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients must be surgical candidates for at least a lobectomy or other anatomical resection (via either video-assisted thoracoscopic surgery, or open approach).",
            "criterions": [
                {
                    "exact_snippets": "Patients must be surgical candidates for at least a lobectomy or other anatomical resection",
                    "criterion": "surgical candidacy",
                    "requirements": [
                        {
                            "requirement_type": "procedure type",
                            "expected_value": [
                                "lobectomy",
                                "other anatomical resection"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "via either video-assisted thoracoscopic surgery, or open approach",
                    "criterion": "surgical approach",
                    "requirements": [
                        {
                            "requirement_type": "approach type",
                            "expected_value": [
                                "video-assisted thoracoscopic surgery",
                                "open approach"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient must have an ECOG/Zubrod score of 0, 1 or 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG/Zubrod score of 0, 1 or 2",
                    "criterion": "ECOG/Zubrod score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients must not have undergone previous invasive mediastinal staging for this cancer.",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have undergone previous invasive mediastinal staging",
                    "criterion": "previous invasive mediastinal staging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients must not have a tracheostomy.",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have a tracheostomy.",
                    "criterion": "tracheostomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient must have a CT of the chest and upper abdomen or an FDG-PET scan performed within 60 days of enrollment to the study that confirms their clinical stage I status. Both scans must be performed, only one needs to be within 60 days of enrollment to the study.",
            "criterions": [
                {
                    "exact_snippets": "CT of the chest and upper abdomen",
                    "criterion": "CT scan",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "chest",
                                "upper abdomen"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "performed"
                        },
                        {
                            "requirement_type": "clinical stage confirmation",
                            "expected_value": "I"
                        }
                    ]
                },
                {
                    "exact_snippets": "FDG-PET scan",
                    "criterion": "FDG-PET scan",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "performed"
                        },
                        {
                            "requirement_type": "clinical stage confirmation",
                            "expected_value": "I"
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 60 days of enrollment",
                    "criterion": "scan timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "There are no separately noted exclusion criteria. All criteria are listed under inclusion.",
            "criterions": [
                {
                    "exact_snippets": "no separately noted exclusion criteria",
                    "criterion": "exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "All criteria are listed under inclusion",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}