{
    "info": {
        "nct_id": "NCT00339248",
        "official_title": "Risk of Breast Cancer and Hyperplastic Conditions in the Breast Cancer Serum Bank in Relation to Inherited Genetic Variants",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 15 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* INCLUSION/EXCLUSION CRITERIA:\n\nPotentially eligible premenopausal women include 2636 who did not have a previous or concurrent (within 60 days) diagnosis of breast cancer at the time of initial benign breast biopsy (study entry) and who have at least 4 mls of serum stored in the Frederick biorepository.\n\nOf those 2636, four women have a code indicating \"refused study\" in the \"follow-up\" variable, and despite evidence of their consent to the original study, will be omitted from all future use of study data or specimens.\n\nParticipants also will be required to be Caucasian or African American (2599 or 98.6%), and to have a pathology report successfully retrieved from a participating hospital for review.\n\nAll sample sizes subsequently cited in the text take these inclusion criteria into account, and those cited for objective 2 also incorporate adjustment for loss to follow-up."
    },
    "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"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 15 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 15 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "Potentially eligible premenopausal women include 2636 who did not have a previous or concurrent (within 60 days) diagnosis of breast cancer at the time of initial benign breast biopsy (study entry) and who have at least 4 mls of serum stored in the Frederick biorepository.",
            "criterions": [
                {
                    "exact_snippets": "premenopausal women",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "did not have a previous or concurrent (within 60 days) diagnosis of breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "at the time of initial benign breast biopsy (study entry)",
                    "criterion": "initial biopsy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "benign"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 4 mls of serum stored in the Frederick biorepository",
                    "criterion": "serum storage",
                    "requirements": [
                        {
                            "requirement_type": "volume",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "mls"
                            }
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "Frederick biorepository"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Of those 2636, four women have a code indicating \"refused study\" in the \"follow-up\" variable, and despite evidence of their consent to the original study, will be omitted from all future use of study data or specimens.",
            "criterions": [
                {
                    "exact_snippets": "code indicating \"refused study\" in the \"follow-up\" variable",
                    "criterion": "refusal to participate in follow-up",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of their consent to the original study",
                    "criterion": "consent to original study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Participants also will be required to be Caucasian or African American (2599 or 98.6%), and to have a pathology report successfully retrieved from a participating hospital for review.",
            "criterions": [
                {
                    "exact_snippets": "Participants also will be required to be Caucasian or African American",
                    "criterion": "ethnicity",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "Caucasian",
                                "African American"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "pathology report successfully retrieved from a participating hospital for review",
                    "criterion": "pathology report",
                    "requirements": [
                        {
                            "requirement_type": "retrieval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "All sample sizes subsequently cited in the text take these inclusion criteria into account, and those cited for objective 2 also incorporate adjustment for loss to follow-up.",
            "criterions": [
                {
                    "exact_snippets": "loss to follow-up",
                    "criterion": "loss to follow-up",
                    "requirements": [
                        {
                            "requirement_type": "adjustment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* INCLUSION/EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}