{
    "info": {
        "nct_id": "NCT04109131",
        "official_title": "A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program",
        "inclusion_criteria": "1. Age ≥ 18 years old\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n3. Female or Male\n4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).\n\n   Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program\n\n   Seven cohorts of subjects are defined in this prospective multicenter study:\n   * Cohort 1: Triple negative breast cancer (TNBC)\n   * Cohort 2: HER 2 positive breast cancer (HER2+ BC)\n   * Cohort 3: Non-small cell lung cancer (NSCLC)\n   * Cohort 4: Small cell lung cancer (SCLC)\n   * Cohort 5: Melanoma\n   * Cohort 6: Other solid tumours (apart from the above mentioned subtypes\n   * Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis\n5. Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.\n6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications\n7. Predicted life expectancy > 3 months.\n8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment\n9. Effective contraception is in place for women of childbearing potential\n10. Completion of all necessary screening procedures within 28 days prior to enrolment.\n11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\n    Inclusion criterion applicable to FRANCE only\n12. Affiliated to the French Social Security System\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Pregnant and/or lactating women.\n2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.\n3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n\n   Exclusion criterion applicable to FRANCE only\n4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥ 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Female or Male",
            "criterions": [
                {
                    "exact_snippets": "Female or Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "Female",
                                "Male"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).",
            "criterions": [
                {
                    "exact_snippets": "newly diagnosed or up to 24 months from diagnosis of non-CNS metastases",
                    "criterion": "non-CNS metastases diagnosis time",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2+ BC (cohort 2)",
                    "criterion": "HER2+ breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC harbouring driver mutations (cohort 3)",
                    "criterion": "NSCLC with driver mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program",
            "criterions": [
                {
                    "exact_snippets": "Subjects (from cohorts 1 to 7)",
                    "criterion": "cohort",
                    "requirements": [
                        {
                            "requirement_type": "membership",
                            "expected_value": [
                                "1",
                                "2",
                                "3",
                                "4",
                                "5",
                                "6",
                                "7"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "presenting with a first CNS event",
                    "criterion": "CNS event",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": "first"
                        }
                    ]
                },
                {
                    "exact_snippets": "not yet enrolled in the program",
                    "criterion": "program enrollment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Seven cohorts of subjects are defined in this prospective multicenter study:",
            "criterions": [
                {
                    "exact_snippets": "Seven cohorts of subjects",
                    "criterion": "cohorts of subjects",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 1: Triple negative breast cancer (TNBC)",
            "criterions": [
                {
                    "exact_snippets": "Triple negative breast cancer (TNBC)",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "triple negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 2: HER 2 positive breast cancer (HER2+ BC)",
            "criterions": [
                {
                    "exact_snippets": "HER 2 positive breast cancer (HER2+ BC)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 3: Non-small cell lung cancer (NSCLC)",
            "criterions": [
                {
                    "exact_snippets": "Non-small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 4: Small cell lung cancer (SCLC)",
            "criterions": [
                {
                    "exact_snippets": "Small cell lung cancer (SCLC)",
                    "criterion": "small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 5: Melanoma",
            "criterions": [
                {
                    "exact_snippets": "Melanoma",
                    "criterion": "melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 6: Other solid tumours (apart from the above mentioned subtypes",
            "criterions": [
                {
                    "exact_snippets": "Other solid tumours",
                    "criterion": "solid tumours",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "other"
                        }
                    ]
                },
                {
                    "exact_snippets": "apart from the above mentioned subtypes",
                    "criterion": "solid tumours",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "above mentioned subtypes"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis",
            "criterions": [
                {
                    "exact_snippets": "Radiologically or cytologically confirmed leptomeningeal carcinomatosis",
                    "criterion": "leptomeningeal carcinomatosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "radiologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.",
            "criterions": [
                {
                    "exact_snippets": "Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory",
                    "criterion": "primary and/or non-CNS metastatic archival tumour tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications",
            "criterions": [
                {
                    "exact_snippets": "Willingness to undergo lumbar puncture",
                    "criterion": "willingness to undergo lumbar puncture",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosis of CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless medical contra-indications",
                    "criterion": "medical contra-indications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Predicted life expectancy > 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Predicted life expectancy > 3 months.",
                    "criterion": "predicted life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine pregnancy test",
                    "criterion": "urine pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "done within 28 days prior to enrolment",
                    "criterion": "timing of urine pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Effective contraception is in place for women of childbearing potential",
            "criterions": [
                {
                    "exact_snippets": "Effective contraception is in place for women of childbearing potential",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Completion of all necessary screening procedures within 28 days prior to enrolment.",
            "criterions": [
                {
                    "exact_snippets": "Completion of all necessary screening procedures",
                    "criterion": "screening procedures",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 28 days prior to enrolment",
                    "criterion": "screening procedures",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.",
            "criterions": [
                {
                    "exact_snippets": "Signed Informed Consent form (ICF) obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Inclusion criterion applicable to FRANCE only",
            "criterions": [
                {
                    "exact_snippets": "applicable to FRANCE only",
                    "criterion": "geographic location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "FRANCE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Affiliated to the French Social Security System",
            "criterions": [
                {
                    "exact_snippets": "Affiliated to the French Social Security System",
                    "criterion": "French Social Security System affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "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": "1. Pregnant and/or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.",
            "criterions": [
                {
                    "exact_snippets": "Previous or current malignancies of other histologies within the last 2 years",
                    "criterion": "malignancies of other histologies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell or squamous cell carcinoma of the skin",
                    "criterion": "adequately treated basal cell or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.",
            "criterions": [
                {
                    "exact_snippets": "significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled by treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant ... neuro-psychiatric ... condition, currently uncontrolled by treatment",
                    "criterion": "neuro-psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled by treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant ... surgical condition, currently uncontrolled by treatment",
                    "criterion": "surgical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled by treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Exclusion criterion applicable to FRANCE only",
            "criterions": [
                {
                    "exact_snippets": "Exclusion criterion applicable to FRANCE only",
                    "criterion": "country",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "FRANCE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.",
            "criterions": [
                {
                    "exact_snippets": "Vulnerable persons according to the article L.1121-6 of the Public Health Code",
                    "criterion": "vulnerable persons",
                    "requirements": [
                        {
                            "requirement_type": "legal definition",
                            "expected_value": "article L.1121-6 of the Public Health Code"
                        }
                    ]
                },
                {
                    "exact_snippets": "adults who are the subject of a measure of legal protection",
                    "criterion": "legal protection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "subject of a measure of legal protection"
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to express their consent according to article L.1121-8 of the Public Health Code",
                    "criterion": "ability to express consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "legal definition",
                            "expected_value": "article L.1121-8 of the Public Health Code"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}