{
    "info": {
        "nct_id": "NCT03947762",
        "official_title": "Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice",
        "inclusion_criteria": "* Subjects aged ≥ 18\n* Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months\n* Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation\n* Subject with Eastern Cooperative Oncology Group (ECOG) ≤2\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subject who is participating in an interventional study\n* Pregnant or breast-feeding women\n* Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Subjects aged ≥ 18",
                "criterions": [
                    {
                        "exact_snippets": "aged ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "aged ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months",
                "criterions": [
                    {
                        "exact_snippets": "diagnosed of functioning or non-functioning PanNET",
                        "criterion": "PanNET diagnosis",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "functioning",
                                "non-functioning"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "G1/ G2 (Ki67≤10%)",
                        "criterion": "tumor grade",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": [
                                "G1",
                                "G2"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "G1/ G2 (Ki67≤10%)",
                        "criterion": "tumor grade",
                        "requirement": {
                            "requirement_type": "Ki67 index",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unresectable locally advanced tumour or metastatic disease",
                        "criterion": "tumor resectability and stage",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": "unresectable"
                        }
                    },
                    {
                        "exact_snippets": "unresectable locally advanced tumour or metastatic disease",
                        "criterion": "tumor resectability and stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months",
                        "criterion": "lanreotide treatment duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "diagnosed of functioning or non-functioning PanNET",
                                                                "criterion": "PanNET diagnosis",
                                                                "requirement": {
                                                                    "requirement_type": "type",
                                                                    "expected_value": [
                                                                        "functioning",
                                                                        "non-functioning"
                                                                    ]
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "G1/ G2 (Ki67≤10%)",
                                                                "criterion": "tumor grade",
                                                                "requirement": {
                                                                    "requirement_type": "grade",
                                                                    "expected_value": [
                                                                        "G1",
                                                                        "G2"
                                                                    ]
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "G1/ G2 (Ki67≤10%)",
                                                        "criterion": "tumor grade",
                                                        "requirement": {
                                                            "requirement_type": "Ki67 index",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 10,
                                                                "unit": "%"
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "unresectable locally advanced tumour or metastatic disease",
                                                "criterion": "tumor resectability and stage",
                                                "requirement": {
                                                    "requirement_type": "resectability",
                                                    "expected_value": "unresectable"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "unresectable locally advanced tumour or metastatic disease",
                                        "criterion": "tumor resectability and stage",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": [
                                                "locally advanced",
                                                "metastatic"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months",
                                "criterion": "lanreotide treatment duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "months"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 12,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Subject who is participating in an interventional study",
                "criterions": [
                    {
                        "exact_snippets": "Subject who is participating in an interventional study",
                        "criterion": "participation in an interventional study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Subject who is participating in an interventional study",
                    "criterion": "participation in an interventional study",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or breast-feeding women",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours",
                "criterions": [
                    {
                        "exact_snippets": "received any previous therapy for PanNET",
                        "criterion": "previous therapy for PanNET",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours",
                        "criterion": "short-acting octreotide subcutaneous (SC)",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": "symptomatic control of functioning tumours"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "received any previous therapy for PanNET",
                            "criterion": "previous therapy for PanNET",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours",
                            "criterion": "short-acting octreotide subcutaneous (SC)",
                            "requirement": {
                                "requirement_type": "use",
                                "expected_value": "symptomatic control of functioning tumours"
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "received any previous therapy for PanNET",
                    "criterion": "previous therapy for PanNET",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation",
                "criterions": [
                    {
                        "exact_snippets": "Subject not progressive at inclusion study visit according to investigator assessment",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "not progressive"
                        }
                    },
                    {
                        "exact_snippets": "using as a reference lanreotide initiation",
                        "criterion": "reference point for assessment",
                        "requirement": {
                            "requirement_type": "reference",
                            "expected_value": "lanreotide initiation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subject with Eastern Cooperative Oncology Group (ECOG) ≤2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) ≤2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}