{
    "info": {
        "nct_id": "NCT00539162",
        "official_title": "Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women",
        "inclusion_criteria": "1. Female, >/= 50 years old or less than 75 years old.\n2. Postmenopausal (>/= 12 months amenorrhea).\n3. Have at least one ovary.\n4. Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study.\n5. Willingness to return for CA 125 blood tests annually or earlier if indicated.\n6. Willingness to return to undergo transvaginal ultrasound if indicated.\n7. Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 50 Years\nMust have maximum age of 74 Years",
        "exclusion_criteria": "1. Female: Less than 50 years old or older than 75 years at the time of enrollment.\n2. Psychiatric or psychological or other conditions which prevent a fully informed consent.\n3. Prior removal of both ovaries.\n4. Active non-ovarian malignancy.\n5. Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months. If they are on SERMS (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.\n6. High risk for ovarian cancer due to familial predisposition as defined by the following: a. Known mutation in BRCA1 of BRCA2. b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer & one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal & one post-menopausal breast cancer. (These conditions can also be met using the patient and one 1st or 2nd degree female relative.) c. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer. d. 1st or 2nd degree male relative with breast cancer diagnosed at any age. (First degree relative defined as children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.)\n7. Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Female, >/= 50 years old or less than 75 years old.",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": ">/= 50 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 75,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Postmenopausal (>/= 12 months amenorrhea).",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal (>/= 12 months amenorrhea)",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration of amenorrhea",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have at least one ovary.",
            "criterions": [
                {
                    "exact_snippets": "at least one ovary",
                    "criterion": "ovary",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study.",
            "criterions": [
                {
                    "exact_snippets": "Cancer-free",
                    "criterion": "cancer status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cancer-free"
                        }
                    ]
                },
                {
                    "exact_snippets": "have not received any chemotherapy",
                    "criterion": "chemotherapy history",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have not received any ... radiation therapy",
                    "criterion": "radiation therapy history",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": ">/=12 months prior to enrolling on this study",
                    "criterion": "time since last treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Willingness to return for CA 125 blood tests annually or earlier if indicated.",
            "criterions": [
                {
                    "exact_snippets": "Willingness to return for CA 125 blood tests annually or earlier if indicated.",
                    "criterion": "willingness to return for CA 125 blood tests",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "annually or earlier if indicated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Willingness to return to undergo transvaginal ultrasound if indicated.",
            "criterions": [
                {
                    "exact_snippets": "Willingness to return to undergo transvaginal ultrasound if indicated.",
                    "criterion": "willingness to return for transvaginal ultrasound",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated",
            "criterions": [
                {
                    "exact_snippets": "Women need to provide the name of a gynecologist or qualified healthcare professional",
                    "criterion": "follow-up care provider",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 50 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 50 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 74 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 74 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 74,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Female: Less than 50 years old or older than 75 years at the time of enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "Less than 50 years old or older than 75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Psychiatric or psychological or other conditions which prevent a fully informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric or psychological or other conditions which prevent a fully informed consent.",
                    "criterion": "psychiatric conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on consent",
                            "expected_value": "prevent a fully informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "Psychiatric or psychological or other conditions which prevent a fully informed consent.",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on consent",
                            "expected_value": "prevent a fully informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "Psychiatric or psychological or other conditions which prevent a fully informed consent.",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on consent",
                            "expected_value": "prevent a fully informed consent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior removal of both ovaries.",
            "criterions": [
                {
                    "exact_snippets": "Prior removal of both ovaries.",
                    "criterion": "ovaries",
                    "requirements": [
                        {
                            "requirement_type": "removal",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Active non-ovarian malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Active non-ovarian malignancy",
                    "criterion": "non-ovarian malignancy",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months. If they are on SERMS (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.",
            "criterions": [
                {
                    "exact_snippets": "Women who have a history of non-ovarian malignancy",
                    "criterion": "history of non-ovarian malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no persistent or recurrent disease",
                    "criterion": "persistent or recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have not received treatment for >12 months",
                    "criterion": "treatment for non-ovarian malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on SERMS (i.e. tamoxifen or aromatase inhibitors)",
                    "criterion": "use of SERMS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment <12 months prior to study entry for basal cell carcinoma only",
                    "criterion": "treatment for basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. High risk for ovarian cancer due to familial predisposition as defined by the following: a. Known mutation in BRCA1 of BRCA2. b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer & one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal & one post-menopausal breast cancer. (These conditions can also be met using the patient and one 1st or 2nd degree female relative.) c. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer. d. 1st or 2nd degree male relative with breast cancer diagnosed at any age. (First degree relative defined as children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.)",
            "criterions": [
                {
                    "exact_snippets": "Known mutation in BRCA1 of BRCA2",
                    "criterion": "BRCA1 or BRCA2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers",
                    "criterion": "family history of ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 2"
                        }
                    ]
                },
                {
                    "exact_snippets": "Two 1st or 2nd degree relatives of same lineage who have: ... one ovarian cancer & one pre-menopausal breast cancer",
                    "criterion": "family history of ovarian cancer and pre-menopausal breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Two 1st or 2nd degree relatives of same lineage who have: ... two pre-menopausal breast cancers",
                    "criterion": "family history of pre-menopausal breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 2"
                        }
                    ]
                },
                {
                    "exact_snippets": "Two 1st or 2nd degree relatives of same lineage who have: ... one pre-menopausal & one post-menopausal breast cancer",
                    "criterion": "family history of pre-menopausal and post-menopausal breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer",
                    "criterion": "Ashkenazi Jewish descent with family history of pre-menopausal breast or ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participant has had pre-menopausal breast cancer",
                    "criterion": "pre-menopausal breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "1st or 2nd degree male relative with breast cancer diagnosed at any age",
                    "criterion": "family history of male breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.",
            "criterions": [
                {
                    "exact_snippets": "Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome",
                    "criterion": "Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known genetic mutation",
                    "criterion": "genetic mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presumed HNPCC carrier",
                    "criterion": "HNPCC carrier status",
                    "requirements": [
                        {
                            "requirement_type": "presumed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Amsterdam criteria",
                    "criterion": "Amsterdam criteria",
                    "requirements": [
                        {
                            "requirement_type": "fulfillment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}