{
    "info": {
        "nct_id": "NCT04275557",
        "official_title": "Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology",
        "inclusion_criteria": "* Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas.\n* Able to understand and voluntarily sign the informed consent.\n* Willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* No suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis.\n* Has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation).\n* Unable to provide informed consent.\n* Unwilling to complete study questionnaire(s) and/or donate biological specimens or images.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas.",
            "criterions": [
                {
                    "exact_snippets": "present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM",
                    "criterion": "location of presentation",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "GI clinic",
                                "surgery",
                                "endoscopy at Moffitt",
                                "Florida Research Institute (FRI)",
                                "UM"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis",
                    "criterion": "pancreatic condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "pancreatic lesion",
                                "cyst",
                                "mass",
                                "cancer",
                                "pancreatitis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "based on symptoms, imaging, or blood-work",
                    "criterion": "basis for suspicion or diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "symptoms",
                                "imaging",
                                "blood-work"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "has not had any treatment involving their pancreas",
                    "criterion": "prior pancreatic treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to understand and voluntarily sign the informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Able to understand and voluntarily sign the informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "voluntary signing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Willing to complete study questionnaire(s)",
                    "criterion": "willingness to complete study questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "donate medical images and/or biological specimens",
                    "criterion": "willingness to donate medical images and/or biological specimens",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signing the informed consent document",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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": "* No suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis.",
            "criterions": [
                {
                    "exact_snippets": "No suspicion or diagnosis of a pancreatic lesion",
                    "criterion": "pancreatic lesion",
                    "requirements": [
                        {
                            "requirement_type": "suspicion or diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No suspicion or diagnosis of a pancreatic ... cyst",
                    "criterion": "pancreatic cyst",
                    "requirements": [
                        {
                            "requirement_type": "suspicion or diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No suspicion or diagnosis of a pancreatic ... mass",
                    "criterion": "pancreatic mass",
                    "requirements": [
                        {
                            "requirement_type": "suspicion or diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No suspicion or diagnosis of a pancreatic ... cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "suspicion or diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No suspicion or diagnosis of a pancreatic ... pancreatitis",
                    "criterion": "pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "suspicion or diagnosis",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation).",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis",
                    "criterion": "pancreatic condition",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "pancreatic lesion",
                                "cyst",
                                "mass",
                                "cancer",
                                "pancreatitis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "has already undergone treatment involving the pancreas",
                    "criterion": "treatment involving the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Unable to provide informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unwilling to complete study questionnaire(s) and/or donate biological specimens or images.",
            "criterions": [
                {
                    "exact_snippets": "Unwilling to complete study questionnaire(s)",
                    "criterion": "willingness to complete study questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Unwilling to ... donate biological specimens",
                    "criterion": "willingness to donate biological specimens",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Unwilling to ... donate ... images",
                    "criterion": "willingness to donate images",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}