{
    "info": {
        "nct_id": "NCT03840460",
        "official_title": "A Prospective Translational Tissue Collection Study in Early and Advanced Pancreatic Ductal Adenocarcinoma (PDAC) and Pancreatic Neuroendocrine Tumours (PanNETs) to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers",
        "inclusion_criteria": "1. Patient is being investigated or treated for pancreatic cancer or precursor lesions at The Royal Marsden Hospital and referring centres during the study period.\n2. Patient has a histologically/cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma, or pancreatic neuroendocrine tumour OR Patient has a tissue lesion suspicious for pancreatic cancer amenable to core needle biopsy or surgery and is clinically fit enough to undergo a tumour biopsy or surgery according to investigator assessment and local guidelines.\n3. Patient is ≥ 18 years of age.\n4. Patient can understand the patient information sheet and is able to provide written informed consent.\n5. Patient has sufficient tissue and/or blood and/or urine and/or stool and/or saliva sampling for analysis as per the protocol.\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients who are not treated at all at The Royal Marsden Hospital or referring centre.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient is being investigated or treated for pancreatic cancer or precursor lesions at The Royal Marsden Hospital and referring centres during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Patient is being investigated or treated for pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "investigation or treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "precursor lesions",
                    "criterion": "precursor lesions",
                    "requirements": [
                        {
                            "requirement_type": "investigation or treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at The Royal Marsden Hospital and referring centres",
                    "criterion": "treatment location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "The Royal Marsden Hospital",
                                "referring centres"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient has a histologically/cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma, or pancreatic neuroendocrine tumour OR Patient has a tissue lesion suspicious for pancreatic cancer amenable to core needle biopsy or surgery and is clinically fit enough to undergo a tumour biopsy or surgery according to investigator assessment and local guidelines.",
            "criterions": [
                {
                    "exact_snippets": "histologically/cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma",
                    "criterion": "pancreatic ductal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically/cytologically confirmed diagnosis of ... pancreatic neuroendocrine tumour",
                    "criterion": "pancreatic neuroendocrine tumour",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tissue lesion suspicious for pancreatic cancer",
                    "criterion": "tissue lesion suspicious for pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to core needle biopsy or surgery",
                    "criterion": "tissue lesion amenability",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": [
                                "core needle biopsy",
                                "surgery"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically fit enough to undergo a tumour biopsy or surgery",
                    "criterion": "clinical fitness for procedure",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": [
                                "tumour biopsy",
                                "surgery"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "according to investigator assessment and local guidelines",
                    "criterion": "investigator assessment and local guidelines",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient is ≥ 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patient is ≥ 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient can understand the patient information sheet and is able to provide written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patient can understand the patient information sheet",
                    "criterion": "understanding of patient information sheet",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is able to provide written informed consent",
                    "criterion": "ability to provide written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient has sufficient tissue and/or blood and/or urine and/or stool and/or saliva sampling for analysis as per the protocol.",
            "criterions": [
                {
                    "exact_snippets": "sufficient tissue",
                    "criterion": "tissue sampling",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient ... blood",
                    "criterion": "blood sampling",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient ... urine",
                    "criterion": "urine sampling",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient ... stool",
                    "criterion": "stool sampling",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient ... saliva sampling",
                    "criterion": "saliva sampling",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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. Patients who are not treated at all at The Royal Marsden Hospital or referring centre.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are not treated at all at The Royal Marsden Hospital or referring centre.",
                    "criterion": "treatment location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "The Royal Marsden Hospital",
                                "referring centre"
                            ]
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}