{
    "info": {
        "nct_id": "NCT06500494",
        "official_title": "Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL",
        "inclusion_criteria": "Female aged ≥ 18 years (≥ 19 years for Algeria as per local regulation) at oral vinorelbine ( OV) -based treatment initiation\n\nConfirmed diagnosis of locally advanced or metastatic breast cancer eligible for chemotherapy\n\nInitiated OV-based treatment as per SmPC for advanced breast cancer between January 2011 and December 2020 for the retrospective cohort or, initiating oral vinorelbine treatment at enrollment for the prospective cohort\n\nWilling and able to complete the QoL questionnaire, PPQ and WPAI questionnaire for the prospective cohort\n\nProvision of informed consent or non-opposition to the patient (or next of kin/legal representative, if applicable) for the use of data, according to local regulations\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "no exclusion criteria for patients in this study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Female aged ≥ 18 years (≥ 19 years for Algeria as per local regulation) at oral vinorelbine ( OV) -based treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥ 18 years (≥ 19 years for Algeria as per local regulation)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 19,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "oral vinorelbine ( OV) -based treatment initiation",
                    "criterion": "treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "oral vinorelbine-based"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Confirmed diagnosis of locally advanced or metastatic breast cancer eligible for chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of locally advanced or metastatic breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for chemotherapy",
                    "criterion": "chemotherapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Initiated OV-based treatment as per SmPC for advanced breast cancer between January 2011 and December 2020 for the retrospective cohort or, initiating oral vinorelbine treatment at enrollment for the prospective cohort",
            "criterions": [
                {
                    "exact_snippets": "Initiated OV-based treatment as per SmPC for advanced breast cancer between January 2011 and December 2020 for the retrospective cohort",
                    "criterion": "OV-based treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2011,
                                        "unit": "year"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2020,
                                        "unit": "year"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "advanced breast cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "initiating oral vinorelbine treatment at enrollment for the prospective cohort",
                    "criterion": "oral vinorelbine treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Willing and able to complete the QoL questionnaire, PPQ and WPAI questionnaire for the prospective cohort",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to complete the QoL questionnaire",
                    "criterion": "QoL questionnaire completion",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to complete the ... PPQ",
                    "criterion": "PPQ completion",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to complete the ... WPAI questionnaire",
                    "criterion": "WPAI questionnaire completion",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Provision of informed consent or non-opposition to the patient (or next of kin/legal representative, if applicable) for the use of data, according to local regulations",
            "criterions": [
                {
                    "exact_snippets": "Provision of informed consent or non-opposition to the patient (or next of kin/legal representative, if applicable) for the use of data",
                    "criterion": "informed consent or non-opposition",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "according to local regulations",
                    "criterion": "compliance with local regulations",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 exclusion criteria for patients in this study",
            "criterions": [
                {
                    "exact_snippets": "no exclusion criteria",
                    "criterion": "exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}