{
    "info": {
        "nct_id": "NCT02206360",
        "official_title": "Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing",
        "inclusion_criteria": "Any of the following:\n\n1. Known carrier of either the BRCA2 or CDKN2A mutation;\n2. Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer;\n3. Individual with Peutz-Jeghers Syndrome;\n4. Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject;\n5. Both parents affected, any age:\n6. Any first degree relative diagnosed with pancreatic cancer under age 50;\n7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Any medical condition that contraindicates endoscopy or biopsy\n2. Any medical condition that contraindicates MRI\n3. Status post partial or complete resection of the pancreas\n4. History of pancreatic cancer, either endocrine or exocrine\n5. Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).\n6. diagnosis of dementia\n7. Uncontrolled, current illness\n8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Any of the following:",
            "criterions": [
                {
                    "exact_snippets": "Any of the following",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Known carrier of either the BRCA2 or CDKN2A mutation;",
            "criterions": [
                {
                    "exact_snippets": "Known carrier of either the BRCA2 or CDKN2A mutation",
                    "criterion": "BRCA2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known carrier of either the BRCA2 or CDKN2A mutation",
                    "criterion": "CDKN2A mutation",
                    "requirements": [
                        {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer;",
            "criterions": [
                {
                    "exact_snippets": "Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM)",
                    "criterion": "genetic mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "BRCA1",
                                "MLH1",
                                "MSH2",
                                "PMS2",
                                "MSH6",
                                "EPCAM",
                                "P53",
                                "PALB2",
                                "APC",
                                "ATM"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "first or second degree relative affected with pancreatic cancer",
                    "criterion": "family history of pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "relation degree",
                            "expected_value": [
                                "first",
                                "second"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Individual with Peutz-Jeghers Syndrome;",
            "criterions": [
                {
                    "exact_snippets": "Individual with Peutz-Jeghers Syndrome",
                    "criterion": "Peutz-Jeghers Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject;",
            "criterions": [
                {
                    "exact_snippets": "Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer",
                    "criterion": "familial pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "at least two affected relatives with Pancreatic Cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "who are first degree relatives with each other",
                    "criterion": "first degree relatives",
                    "requirements": [
                        {
                            "requirement_type": "relationship",
                            "expected_value": "first degree relatives with each other"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one of those affected must be first degree relative to the study subject",
                    "criterion": "first degree relative to the study subject",
                    "requirements": [
                        {
                            "requirement_type": "relationship",
                            "expected_value": "first degree relative to the study subject"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Both parents affected, any age:",
            "criterions": [
                {
                    "exact_snippets": "Both parents affected",
                    "criterion": "parental health status",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "affected"
                        }
                    ]
                },
                {
                    "exact_snippets": "any age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Any first degree relative diagnosed with pancreatic cancer under age 50;",
            "criterions": [
                {
                    "exact_snippets": "first degree relative diagnosed with pancreatic cancer",
                    "criterion": "first degree relative pancreatic cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history",
            "criterions": [
                {
                    "exact_snippets": "Chronic Pancreatitis Syndrome",
                    "criterion": "Chronic Pancreatitis Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PRSS1 or SPINK1 mutations",
                    "criterion": "PRSS1 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PRSS1 or SPINK1 mutations",
                    "criterion": "SPINK1 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriate clinical and family history",
                    "criterion": "clinical history",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriate clinical and family history",
                    "criterion": "family history",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "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 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. Any medical condition that contraindicates endoscopy or biopsy",
            "criterions": [
                {
                    "exact_snippets": "medical condition that contraindicates endoscopy",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": "endoscopy"
                        }
                    ]
                },
                {
                    "exact_snippets": "medical condition that contraindicates ... biopsy",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": "biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Any medical condition that contraindicates MRI",
            "criterions": [
                {
                    "exact_snippets": "Any medical condition that contraindicates MRI",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": "MRI"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Status post partial or complete resection of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "Status post partial or complete resection of the pancreas",
                    "criterion": "resection of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post partial or complete"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of pancreatic cancer, either endocrine or exocrine",
            "criterions": [
                {
                    "exact_snippets": "History of pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "either endocrine or exocrine",
                    "criterion": "type of pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "endocrine",
                                "exocrine"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).",
            "criterions": [
                {
                    "exact_snippets": "Clinical suspicion of pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any previous radiographic or histologic diagnosis of a pre-malignant finding",
                    "criterion": "pre-malignant finding",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including IPMN (Intraductal papillary mucinous neoplasm)",
                    "criterion": "IPMN (Intraductal papillary mucinous neoplasm)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... PanIN (Pancreatic intraepithelial Neoplasm)",
                    "criterion": "PanIN (Pancreatic intraepithelial Neoplasm)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. diagnosis of dementia",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Uncontrolled, current illness",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled, current illness",
                    "criterion": "illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "current",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl",
            "criterions": [
                {
                    "exact_snippets": "Renal insufficiency",
                    "criterion": "renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine greater than 2.0 mg/dl",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}