{
    "info": {
        "nct_id": "NCT00003901",
        "official_title": "A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma",
        "inclusion_criteria": "1. Patient must be ≥ 18 years old.\n2. Patient must have ECOG/Zubrod status < 3.\n3. Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.\n4. Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.\n5. Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.\n6. Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.\n7. Patient must be medically fit for surgery.\n8. Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.\n9. Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.\n10. Patient must be available for follow-up.\n11. If the patient is a survivor of a prior cancer, all of the following criteria must apply:\n\n    1. Patient has undergone potentially curative therapy for all prior malignancies,\n    2. No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),\n    3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.\n2. Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.\n3. Patient has received prior chemotherapy or radiotherapy for this cancer.\n4. Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.\n5. Patient for whom the surgeon plans to perform only a wedge resection for treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient must be ≥ 18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be ≥ 18 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient must have ECOG/Zubrod status < 3.",
            "criterions": [
                {
                    "exact_snippets": "ECOG/Zubrod status < 3",
                    "criterion": "ECOG/Zubrod status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.",
            "criterions": [
                {
                    "exact_snippets": "clinically resectable",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC (squamous cell, adenocarcinoma, or large cell)",
                    "criterion": "NSCLC subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "squamous cell",
                                "adenocarcinoma",
                                "large cell"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical Stage I, IIa, IIb or IIIa",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "IIa",
                                "IIb",
                                "IIIa"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer",
                    "criterion": "staging system",
                    "requirements": [
                        {
                            "requirement_type": "system",
                            "expected_value": "1998 staging system of the American Joint Commission on Cancer for lung cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.",
            "criterions": [
                {
                    "exact_snippets": "Patient must have N1 or N2 disease.",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "N1",
                                "N2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient must undergo mediastinoscopy ... if preoperative studies suggest N3 disease.",
                    "criterion": "mediastinoscopy requirement",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "preoperative studies suggest N3 disease"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "pathologic diagnosis ... of NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "pathologic"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "pre-operative",
                                "intra-operative"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC.",
                    "criterion": "anticipated thoracotomy",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "curative resection for primary NSCLC"
                        }
                    ]
                },
                {
                    "exact_snippets": "preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.",
                    "criterion": "preoperative assessment of resectability",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "CT scan of the chest",
                                "CT scan of the upper abdomen",
                                "CT scan of the adrenal glands"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days prior to registration"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patient must be medically fit for surgery.",
            "criterions": [
                {
                    "exact_snippets": "medically fit for surgery",
                    "criterion": "medical fitness for surgery",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be a candidate for complete resection of the carcinoma",
                    "criterion": "candidate for complete resection of carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection",
                    "criterion": "surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "pneumonectomy",
                                "bilobectomy",
                                "lobectomy",
                                "anatomic segmentectomy"
                            ]
                        },
                        {
                            "requirement_type": "additional procedure",
                            "expected_value": "sleeve resection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.",
            "criterions": [
                {
                    "exact_snippets": "Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patient must be available for follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be available for follow-up.",
                    "criterion": "patient availability for follow-up",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. If the patient is a survivor of a prior cancer, all of the following criteria must apply:",
            "criterions": [
                {
                    "exact_snippets": "survivor of a prior cancer",
                    "criterion": "prior cancer survivorship",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "survivor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Patient has undergone potentially curative therapy for all prior malignancies,",
            "criterions": [
                {
                    "exact_snippets": "Patient has undergone potentially curative therapy for all prior malignancies",
                    "criterion": "prior malignancies",
                    "requirements": [
                        {
                            "requirement_type": "therapy status",
                            "expected_value": "potentially curative therapy undergone"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),",
            "criterions": [
                {
                    "exact_snippets": "No evidence of any prior malignancies for at least 5 years",
                    "criterion": "prior malignancies",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of recurrence",
                    "criterion": "recurrence of malignancies",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for effectively treated basal cell or squamous carcinoma of the skin",
                    "criterion": "basal cell or squamous carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment effectiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... carcinoma in-situ of the cervix that has been effectively treated by surgery alone",
                    "criterion": "carcinoma in-situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment effectiveness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment method",
                            "expected_value": "surgery alone"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone",
                    "criterion": "lobular carcinoma in-situ of the breast",
                    "requirements": [
                        {
                            "requirement_type": "treatment method",
                            "expected_value": "surgery alone"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.",
            "criterions": [
                {
                    "exact_snippets": "low risk for recurrence from prior malignancies",
                    "criterion": "recurrence risk from prior malignancies",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.",
            "criterions": [
                {
                    "exact_snippets": "evidence of pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "by physical assessment",
                    "criterion": "pleural effusion detection method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "physical assessment"
                        }
                    ]
                },
                {
                    "exact_snippets": "by ... lateral chest x-ray",
                    "criterion": "pleural effusion detection method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "lateral chest x-ray"
                        }
                    ]
                },
                {
                    "exact_snippets": "by ... chest CT scan",
                    "criterion": "pleural effusion detection method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "chest CT scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.",
            "criterions": [
                {
                    "exact_snippets": "ipsilateral thoracotomy or thoracoscopy",
                    "criterion": "ipsilateral thoracotomy or thoracoscopy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient has received prior chemotherapy or radiotherapy for this cancer.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has received prior ... radiotherapy for this cancer",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.",
            "criterions": [
                {
                    "exact_snippets": "poor surgical risk",
                    "criterion": "surgical risk",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-malignant systemic disease (cardiovascular, renal, etc.)",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "malignancy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-malignant systemic disease (cardiovascular, renal, etc.)",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that would preclude the treatment options",
                    "criterion": "treatment options",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient for whom the surgeon plans to perform only a wedge resection for treatment.",
            "criterions": [
                {
                    "exact_snippets": "surgeon plans to perform only a wedge resection",
                    "criterion": "planned surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "wedge resection"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}