{
    "info": {
        "nct_id": "NCT03616431",
        "official_title": "Prospective Observational Study of Prevalence, Assessment and Treatment of Pancreatic Insufficiency in Patients With Pancreatic Malignancies",
        "inclusion_criteria": "* Patients with histologically/cytologically-proven or clinically-suspected (by specialist MDT) pancreatic malignancy including pancreatic ductal adenocarcinoma or pancreatic NET.\n* Patients to be seen in the Medical Oncology HPB and NET team clinic for assessment\n* Age ≥18 years with no upper age limit\n* Patients must be able to give informed consent; Written consent will be required for patients to be included within the diagnostic cohort Verbal consent only will be required for patients to be included within the demographic cohort and the follow-up cohort\n\nAdditional cohort-specific criteria;\n\n* Patients will be recruited into three different cohorts with differing levels of participation (termed demographic, diagnostic and follow-up). Patients will not be recruited into the follow-up cohort until recruitment of both demographic and diagnosis cohorts are complete and the interim analysis has been performed.\n* Demographic cohort | All patients referred for consideration of cancer treatment options will be eligible. Patients will need to give verbal informed consent.\n* Diagnosis cohort | Patients who are already consented for being included into the demographic cohort and who will be attending at least to one follow-up appointment and are considered to be fit enough for diagnostic assessment will be eligible. Patients will need to give written informed consent.\n* Follow-up cohort | All patients referred for consideration of options of cancer treatment will be included; patients with a minimum of 3 months of follow-up will be included in the final analysis. Patients will need to give verbal informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "- As long as the inclusion criteria are fulfilled, there are no exclusion criteria.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with histologically/cytologically-proven or clinically-suspected (by specialist MDT) pancreatic malignancy including pancreatic ductal adenocarcinoma or pancreatic NET.",
            "criterions": [
                {
                    "exact_snippets": "histologically/cytologically-proven ... pancreatic malignancy",
                    "criterion": "pancreatic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically-proven",
                                "cytologically-proven"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically-suspected (by specialist MDT) ... pancreatic malignancy",
                    "criterion": "pancreatic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "suspicion method",
                            "expected_value": "clinically-suspected (by specialist MDT)"
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatic ductal adenocarcinoma",
                    "criterion": "pancreatic ductal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatic NET",
                    "criterion": "pancreatic NET",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients to be seen in the Medical Oncology HPB and NET team clinic for assessment",
            "criterions": [
                {
                    "exact_snippets": "Patients to be seen in the Medical Oncology HPB and NET team clinic",
                    "criterion": "clinic location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "Medical Oncology HPB and NET team clinic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years with no upper age limit",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years with no upper age limit",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to give informed consent; Written consent will be required for patients to be included within the diagnostic cohort Verbal consent only will be required for patients to be included within the demographic cohort and the follow-up cohort",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to give informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Written consent will be required for patients to be included within the diagnostic cohort",
                    "criterion": "written consent for diagnostic cohort",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Verbal consent only will be required for patients to be included within the demographic cohort",
                    "criterion": "verbal consent for demographic cohort",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Verbal consent only will be required for patients to be included within ... follow-up cohort",
                    "criterion": "verbal consent for follow-up cohort",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Additional cohort-specific criteria;",
            "criterions": [
                {
                    "exact_snippets": "Additional cohort-specific criteria",
                    "criterion": "cohort-specific criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients will be recruited into three different cohorts with differing levels of participation (termed demographic, diagnostic and follow-up). Patients will not be recruited into the follow-up cohort until recruitment of both demographic and diagnosis cohorts are complete and the interim analysis has been performed.",
            "criterions": [
                {
                    "exact_snippets": "Patients will be recruited into three different cohorts",
                    "criterion": "cohort participation",
                    "requirements": [
                        {
                            "requirement_type": "categories",
                            "expected_value": [
                                "demographic",
                                "diagnostic",
                                "follow-up"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients will not be recruited into the follow-up cohort until recruitment of both demographic and diagnosis cohorts are complete",
                    "criterion": "follow-up cohort recruitment",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "recruitment of both demographic and diagnosis cohorts are complete"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients will not be recruited into the follow-up cohort until ... the interim analysis has been performed",
                    "criterion": "follow-up cohort recruitment",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "interim analysis has been performed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Demographic cohort | All patients referred for consideration of cancer treatment options will be eligible. Patients will need to give verbal informed consent.",
            "criterions": [
                {
                    "exact_snippets": "All patients referred for consideration of cancer treatment options",
                    "criterion": "referral for cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients will need to give verbal informed consent",
                    "criterion": "verbal informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis cohort | Patients who are already consented for being included into the demographic cohort and who will be attending at least to one follow-up appointment and are considered to be fit enough for diagnostic assessment will be eligible. Patients will need to give written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are already consented for being included into the demographic cohort",
                    "criterion": "demographic cohort consent",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "who will be attending at least to one follow-up appointment",
                    "criterion": "follow-up appointment attendance",
                    "requirements": [
                        {
                            "requirement_type": "attendance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered to be fit enough for diagnostic assessment",
                    "criterion": "fitness for diagnostic assessment",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients will need to give written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Follow-up cohort | All patients referred for consideration of options of cancer treatment will be included; patients with a minimum of 3 months of follow-up will be included in the final analysis. Patients will need to give verbal informed consent.",
            "criterions": [
                {
                    "exact_snippets": "All patients referred for consideration of options of cancer treatment",
                    "criterion": "referral for cancer treatment options",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with a minimum of 3 months of follow-up",
                    "criterion": "follow-up duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients will need to give verbal informed consent",
                    "criterion": "verbal informed consent",
                    "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 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": "- As long as the inclusion criteria are fulfilled, there are no exclusion criteria.",
            "criterions": [
                {
                    "exact_snippets": "inclusion criteria are fulfilled",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "fulfillment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}