{
    "info": {
        "nct_id": "NCT01150682",
        "official_title": "Role of Sex Hormone and Insulin/IGF Axes in Endometrial Cancer Recurrence",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed endometrioid endometrial cancer\n\n  * Stage II-IV disease\n* Patients who were eligible and evaluated on the GOG-0210, Molecular Staging in Endometrial Cancer clinical trial, meeting the following criteria:\n\n  * Allowed their specimens and clinical data collected as part of their participation\n  * Have sufficient high-quality frozen primary tumor, formalin-fixed and paraffin-embedded (FFPE) primary tumor, and/or pre-operative serum for testing available\n* Patients who underwent surgical staging as specified in the GOG-0210 protocol and described in the GOG Surgical Manual Protocol, including any of the following procedures:\n\n  * Hysterectomy\n  * Bilateral oophorectomy\n  * Washings as well as pelvic lymphadenectomy and para-aortic lymphadenectomy\n* Non-cancerous endometrial tissue and fasting serum from control samples meeting the following criteria (controls):\n\n  * Underwent hysterectomy to treat uterine prolapse at the Albert Einstein Hospital and Montefiore Medical Center, in the Bronx, NY\n  * No uterine fibroids or prior cancer\n\nPATIENT CHARACTERISTICS:\n\n* Postmenopausal patients and controls\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically confirmed endometrioid endometrial cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed endometrioid endometrial cancer",
                    "criterion": "endometrioid endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage II-IV disease",
            "criterions": [
                {
                    "exact_snippets": "Stage II-IV disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who were eligible and evaluated on the GOG-0210, Molecular Staging in Endometrial Cancer clinical trial, meeting the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "eligible and evaluated on the GOG-0210, Molecular Staging in Endometrial Cancer clinical trial",
                    "criterion": "GOG-0210 trial eligibility and evaluation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allowed their specimens and clinical data collected as part of their participation",
            "criterions": [
                {
                    "exact_snippets": "Allowed their specimens and clinical data collected",
                    "criterion": "specimens and clinical data collection",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have sufficient high-quality frozen primary tumor, formalin-fixed and paraffin-embedded (FFPE) primary tumor, and/or pre-operative serum for testing available",
            "criterions": [
                {
                    "exact_snippets": "sufficient high-quality frozen primary tumor ... available",
                    "criterion": "frozen primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quality",
                            "expected_value": "sufficient high-quality"
                        }
                    ]
                },
                {
                    "exact_snippets": "formalin-fixed and paraffin-embedded (FFPE) primary tumor ... available",
                    "criterion": "FFPE primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-operative serum for testing available",
                    "criterion": "pre-operative serum",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who underwent surgical staging as specified in the GOG-0210 protocol and described in the GOG Surgical Manual Protocol, including any of the following procedures:",
            "criterions": [
                {
                    "exact_snippets": "Patients who underwent surgical staging",
                    "criterion": "surgical staging",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as specified in the GOG-0210 protocol",
                    "criterion": "GOG-0210 protocol",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "described in the GOG Surgical Manual Protocol",
                    "criterion": "GOG Surgical Manual Protocol",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hysterectomy",
            "criterions": [
                {
                    "exact_snippets": "Hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilateral oophorectomy",
            "criterions": [
                {
                    "exact_snippets": "Bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Washings as well as pelvic lymphadenectomy and para-aortic lymphadenectomy",
            "criterions": [
                {
                    "exact_snippets": "Washings",
                    "criterion": "washings",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pelvic lymphadenectomy",
                    "criterion": "pelvic lymphadenectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "para-aortic lymphadenectomy",
                    "criterion": "para-aortic lymphadenectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-cancerous endometrial tissue and fasting serum from control samples meeting the following criteria (controls):",
            "criterions": [
                {
                    "exact_snippets": "Non-cancerous endometrial tissue",
                    "criterion": "endometrial tissue",
                    "requirements": [
                        {
                            "requirement_type": "cancerous status",
                            "expected_value": "non-cancerous"
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting serum",
                    "criterion": "serum",
                    "requirements": [
                        {
                            "requirement_type": "fasting status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Underwent hysterectomy to treat uterine prolapse at the Albert Einstein Hospital and Montefiore Medical Center, in the Bronx, NY",
            "criterions": [
                {
                    "exact_snippets": "Underwent hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "to treat uterine prolapse",
                    "criterion": "uterine prolapse",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at the Albert Einstein Hospital and Montefiore Medical Center, in the Bronx, NY",
                    "criterion": "hospital location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "Albert Einstein Hospital",
                                "Montefiore Medical Center",
                                "Bronx, NY"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uterine fibroids or prior cancer",
            "criterions": [
                {
                    "exact_snippets": "No uterine fibroids",
                    "criterion": "uterine fibroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... prior cancer",
                    "criterion": "prior cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal patients and controls",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal patients",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see details"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}