{
    "info": {
        "nct_id": "NCT01109420",
        "official_title": "Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 7 Years\nMust have maximum age of 90 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* INCLUSION CRITERIA:\n\nSubjects will be selected for this protocol based on either a clinical diagnosis of non-medullary thyroid cancer and the presence of one family member with the disease or the presence of 2 living family members with this disease. Patient selection for this protocol will not be based on gender, race, or ethnic background.\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults or minor (>= 7 years+), males and females.\n* An unaffected individual with (Bullet) 2 first-degree relatives who have or have had nonmedullary thyroid cancer\n\nOR\n\n-An affected individual with documented diagnosis of non-medullary thyroid cancer and (Bullet) one living relative with documented non-medullary thyroid cancer (Note: as this is a familial study, subjects do not need to present with the disease)\n\nOR\n\n* Any member of an affected family. (Note: for this study, an affected family is defined as a family having 2 or more 1st degree relatives with a documented diagnosis of FNMTC.)\n* Adults must be able to understand and the willingness to sign the informed consent document.\n* Adults must be able to complete the family history questionnaire.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be not be allowed to enroll in this study:\n\n-Subjects unwilling/unable to give informed consent."
    },
    "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 have minimum age of 7 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 7 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 90 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 90 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "Subjects will be selected for this protocol based on either a clinical diagnosis of non-medullary thyroid cancer and the presence of one family member with the disease or the presence of 2 living family members with this disease. Patient selection for this protocol will not be based on gender, race, or ethnic background.",
            "criterions": [
                {
                    "exact_snippets": "clinical diagnosis of non-medullary thyroid cancer",
                    "criterion": "non-medullary thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of one family member with the disease",
                    "criterion": "family member with non-medullary thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of 2 living family members with this disease",
                    "criterion": "living family members with non-medullary thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "family members"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adults or minor (>= 7 years+), males and females.",
            "criterions": [
                {
                    "exact_snippets": "Adults or minor (>= 7 years+)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "males and females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* An unaffected individual with (Bullet) 2 first-degree relatives who have or have had nonmedullary thyroid cancer",
            "criterions": [
                {
                    "exact_snippets": "unaffected individual",
                    "criterion": "individual health status",
                    "requirements": [
                        {
                            "requirement_type": "health status",
                            "expected_value": "unaffected"
                        }
                    ]
                },
                {
                    "exact_snippets": "2 first-degree relatives who have or have had nonmedullary thyroid cancer",
                    "criterion": "family history of nonmedullary thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "number of relatives",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "first-degree relatives"
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "nonmedullary thyroid cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "-An affected individual with documented diagnosis of non-medullary thyroid cancer and (Bullet) one living relative with documented non-medullary thyroid cancer (Note: as this is a familial study, subjects do not need to present with the disease)",
            "criterions": [
                {
                    "exact_snippets": "affected individual with documented diagnosis of non-medullary thyroid cancer",
                    "criterion": "non-medullary thyroid cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "one living relative with documented non-medullary thyroid cancer",
                    "criterion": "living relative with non-medullary thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any member of an affected family. (Note: for this study, an affected family is defined as a family having 2 or more 1st degree relatives with a documented diagnosis of FNMTC.)",
            "criterions": [
                {
                    "exact_snippets": "Any member of an affected family ... 2 or more 1st degree relatives with a documented diagnosis of FNMTC.",
                    "criterion": "family history of FNMTC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "number of affected relatives",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "1st degree relatives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adults must be able to understand and the willingness to sign the informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Adults",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "adults"
                        }
                    ]
                },
                {
                    "exact_snippets": "must be able to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": "understand"
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign the informed consent document",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adults must be able to complete the family history questionnaire.",
            "criterions": [
                {
                    "exact_snippets": "Adults must be able to complete the family history questionnaire.",
                    "criterion": "ability to complete family history questionnaire",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "-Subjects unwilling/unable to give informed consent.",
            "criterions": [
                {
                    "exact_snippets": "unwilling/unable to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "In order to be eligible to participate in this study, an individual must meet all of the following criteria:",
            "criterions": []
        },
        {
            "line": "OR",
            "criterions": []
        },
        {
            "line": "OR",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "An individual who meets any of the following criteria will be not be allowed to enroll in this study:",
            "criterions": []
        }
    ]
}