{
    "info": {
        "nct_id": "NCT00991991",
        "official_title": "Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma",
        "inclusion_criteria": "* Node positive Group (experimental group)\n\n  * Primary melanoma > 2 mm in depth\n  * Metastasis must be > 0.1 mm and detectable by IHC or hematoxylin and eosin (H&E) to be considered node positive\n  * Slides and block for primary and node must be archived in UH dermatopathology\n* Node Negative Group (control group)\n\n  * Primary melanoma > 2 mm in depth\n  * A negative sentinel lymph node must be negative by IHC and H&E\n\n    * No stage IV disease\n    * No acral and mucosal histology\n    * No history of prior invasive melanoma\n    * Underwent primary excision and sentinel lymph node biopsy within 3 months of each other\n    * Archived tissue available\n  * Slides and block for primary tumor and node biopsy must be archived in University Hospitals Case Medical Center (UH) dermatopathology\nHealthy volunteers allowed",
        "exclusion_criteria": "* Acral and mucosal histology\n* Previous diagnosis of invasive melanoma\n* previous chemotherapy or immunotherapy\n* patients who are found to have stage IV disease during workup",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Node positive Group (experimental group)",
            "criterions": [
                {
                    "exact_snippets": "Node positive",
                    "criterion": "node status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary melanoma > 2 mm in depth",
            "criterions": [
                {
                    "exact_snippets": "Primary melanoma > 2 mm in depth",
                    "criterion": "primary melanoma depth",
                    "requirements": [
                        {
                            "requirement_type": "depth",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastasis must be > 0.1 mm and detectable by IHC or hematoxylin and eosin (H&E) to be considered node positive",
            "criterions": [
                {
                    "exact_snippets": "Metastasis must be > 0.1 mm",
                    "criterion": "metastasis size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.1,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "detectable by IHC or hematoxylin and eosin (H&E)",
                    "criterion": "metastasis detection method",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "IHC",
                                "hematoxylin and eosin (H&E)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Slides and block for primary and node must be archived in UH dermatopathology",
            "criterions": [
                {
                    "exact_snippets": "Slides and block for primary and node must be archived in UH dermatopathology",
                    "criterion": "slides and block for primary and node",
                    "requirements": [
                        {
                            "requirement_type": "archival location",
                            "expected_value": "UH dermatopathology"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Node Negative Group (control group)",
            "criterions": [
                {
                    "exact_snippets": "Node Negative",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary melanoma > 2 mm in depth",
            "criterions": [
                {
                    "exact_snippets": "Primary melanoma > 2 mm in depth",
                    "criterion": "primary melanoma depth",
                    "requirements": [
                        {
                            "requirement_type": "depth",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A negative sentinel lymph node must be negative by IHC and H&E",
            "criterions": [
                {
                    "exact_snippets": "A negative sentinel lymph node must be negative by IHC",
                    "criterion": "sentinel lymph node",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative by IHC"
                        }
                    ]
                },
                {
                    "exact_snippets": "A negative sentinel lymph node must be negative by ... H&E",
                    "criterion": "sentinel lymph node",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative by H&E"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No stage IV disease",
            "criterions": [
                {
                    "exact_snippets": "No stage IV disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "not stage IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No acral and mucosal histology",
            "criterions": [
                {
                    "exact_snippets": "No acral and mucosal histology",
                    "criterion": "acral histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No acral and mucosal histology",
                    "criterion": "mucosal histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of prior invasive melanoma",
            "criterions": [
                {
                    "exact_snippets": "No history of prior invasive melanoma",
                    "criterion": "invasive melanoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Underwent primary excision and sentinel lymph node biopsy within 3 months of each other",
            "criterions": [
                {
                    "exact_snippets": "Underwent primary excision",
                    "criterion": "primary excision",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sentinel lymph node biopsy",
                    "criterion": "sentinel lymph node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 3 months of each other",
                    "criterion": "time between primary excision and sentinel lymph node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Archived tissue available",
            "criterions": [
                {
                    "exact_snippets": "Archived tissue available",
                    "criterion": "archived tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Slides and block for primary tumor and node biopsy must be archived in University Hospitals Case Medical Center (UH) dermatopathology",
            "criterions": [
                {
                    "exact_snippets": "Slides and block for primary tumor and node biopsy must be archived",
                    "criterion": "slides and block for primary tumor and node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "archival location",
                            "expected_value": "University Hospitals Case Medical Center (UH) dermatopathology"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Acral and mucosal histology",
            "criterions": [
                {
                    "exact_snippets": "Acral and mucosal histology",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acral",
                                "mucosal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous diagnosis of invasive melanoma",
            "criterions": [
                {
                    "exact_snippets": "Previous diagnosis of invasive melanoma",
                    "criterion": "invasive melanoma",
                    "requirements": [
                        {
                            "requirement_type": "previous diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* previous chemotherapy or immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "previous chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous ... immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patients who are found to have stage IV disease during workup",
            "criterions": [
                {
                    "exact_snippets": "stage IV disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}