{
    "info": {
        "nct_id": "NCT06638294",
        "official_title": "A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study",
        "inclusion_criteria": "* Male or female, aged 18 or older\n* History of breast cancer (any subtype)\n* Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.\n* Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.\n* Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.\nHealthy volunteers allowed\nMust have minimum age of 18 Weeks",
        "exclusion_criteria": "* Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor\n* Not eligible for treatment of leptomeningeal disease.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female, aged 18 or older",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of breast cancer (any subtype)",
            "criterions": [
                {
                    "exact_snippets": "History of breast cancer (any subtype)",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "subtype",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.",
            "criterions": [
                {
                    "exact_snippets": "Suspected breast cancer-related leptomeningeal metastasis",
                    "criterion": "breast cancer-related leptomeningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis)",
                    "criterion": "clinical signs or symptoms of leptomeningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiographic",
                    "criterion": "radiographic evidence of leptomeningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrospinal fluid analysis",
                    "criterion": "cerebrospinal fluid analysis for leptomeningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.",
            "criterions": [
                {
                    "exact_snippets": "Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis)",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score of ≤3",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky performance status ≥60",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 Weeks",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Weeks",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor",
            "criterions": [
                {
                    "exact_snippets": "Suspected central nervous system recurrence of hematologic malignancy",
                    "criterion": "central nervous system recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Suspected central nervous system recurrence of ... lymphoma",
                    "criterion": "central nervous system recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Suspected central nervous system recurrence of ... other solid tumor",
                    "criterion": "central nervous system recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not eligible for treatment of leptomeningeal disease.",
            "criterions": [
                {
                    "exact_snippets": "Not eligible for treatment of leptomeningeal disease.",
                    "criterion": "treatment of leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}