{
    "info": {
        "nct_id": "NCT03027427",
        "official_title": "Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 2 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* INCLUSION CRITERIA:\n* Patients with any of the following are eligible:\n\n  * Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology in a CLIA-certified laboratory;\n  * Suspicious lesions not yet confirmed, but considered likely to be related to the stomach pending further evaluation;\n  * Confirmed, deleterious germline mutation (including but not limited to HDGC, GAPPS) known to predispose to gastric tumors;\n  * Confirmed or suspicious heritable gastric malignancy disorder;\n  * Clinically suspicious personal or family medical history of gastric cancer or gastric cancer syndrome that warrants genetics evaluation.\n* Patients must have an ECOG performance score of 0-2.\n* Age greater than or equal to 2 years. Note: Patients greater than or equal to 2 and less than or equal to 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures.\n* The patient is a candidate for the clinically indicated medical evaluations that are being offered\n* Ability of subject, their parents/guardians or legally authorized representative (LAR) to understand and must be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nCandidates who do not meet the inclusion criteria."
    },
    "inclusion_lines": [
        {
            "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 2 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 2 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Patients with any of the following are eligible:",
            "criterions": [
                {
                    "exact_snippets": "Patients with any of the following are eligible",
                    "criterion": "eligibility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology in a CLIA-certified laboratory;",
            "criterions": [
                {
                    "exact_snippets": "Malignant or non-invasive, neoplastic lesions of the stomach",
                    "criterion": "neoplastic lesions of the stomach",
                    "requirements": [
                        {
                            "requirement_type": "malignancy",
                            "expected_value": [
                                "malignant",
                                "non-invasive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by histopathology or cytopathology",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histopathology",
                                "cytopathology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in a CLIA-certified laboratory",
                    "criterion": "laboratory certification",
                    "requirements": [
                        {
                            "requirement_type": "certification",
                            "expected_value": "CLIA-certified"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suspicious lesions not yet confirmed, but considered likely to be related to the stomach pending further evaluation;",
            "criterions": [
                {
                    "exact_snippets": "Suspicious lesions not yet confirmed, but considered likely to be related to the stomach",
                    "criterion": "suspicious lesions",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "relation to stomach",
                            "expected_value": "likely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed, deleterious germline mutation (including but not limited to HDGC, GAPPS) known to predispose to gastric tumors;",
            "criterions": [
                {
                    "exact_snippets": "Confirmed, deleterious germline mutation ... known to predispose to gastric tumors",
                    "criterion": "germline mutation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "deleterious",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "predisposition",
                            "expected_value": "gastric tumors"
                        }
                    ]
                },
                {
                    "exact_snippets": "HDGC, GAPPS",
                    "criterion": "specific germline mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "HDGC",
                                "GAPPS"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed or suspicious heritable gastric malignancy disorder;",
            "criterions": [
                {
                    "exact_snippets": "Confirmed or suspicious heritable gastric malignancy disorder",
                    "criterion": "heritable gastric malignancy disorder",
                    "requirements": [
                        {
                            "requirement_type": "confirmation status",
                            "expected_value": [
                                "confirmed",
                                "suspicious"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically suspicious personal or family medical history of gastric cancer or gastric cancer syndrome that warrants genetics evaluation.",
            "criterions": [
                {
                    "exact_snippets": "Clinically suspicious personal ... medical history of gastric cancer",
                    "criterion": "personal medical history of gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": "clinically suspicious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically suspicious ... family medical history of gastric cancer",
                    "criterion": "family medical history of gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": "clinically suspicious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically suspicious personal or family medical history of ... gastric cancer syndrome",
                    "criterion": "personal or family medical history of gastric cancer syndrome",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": "clinically suspicious"
                        }
                    ]
                },
                {
                    "exact_snippets": "warrants genetics evaluation",
                    "criterion": "genetics evaluation",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have an ECOG performance score of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance score of 0-2",
                    "criterion": "ECOG performance score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age greater than or equal to 2 years. Note: Patients greater than or equal to 2 and less than or equal to 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures.",
            "criterions": [
                {
                    "exact_snippets": "Age greater than or equal to 2 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients greater than or equal to 2 and less than or equal to 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tissue acquisition is performed during a clinically indicated surgical procedure",
                    "criterion": "tissue acquisition",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "performed during a clinically indicated surgical procedure"
                        }
                    ]
                },
                {
                    "exact_snippets": "sampling of tissue, blood and urine does not add risk to the clinically indicated procedures",
                    "criterion": "sampling risk",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "does not add risk to the clinically indicated procedures"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is a candidate for the clinically indicated medical evaluations that are being offered",
            "criterions": [
                {
                    "exact_snippets": "The patient is a candidate for the clinically indicated medical evaluations",
                    "criterion": "candidate for medical evaluations",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability of subject, their parents/guardians or legally authorized representative (LAR) to understand and must be willing to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability of subject, their parents/guardians or legally authorized representative (LAR) to understand",
                    "criterion": "understanding of informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to sign a written informed consent document",
                    "criterion": "willingness to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Candidates who do not meet the inclusion criteria.",
            "criterions": [
                {
                    "exact_snippets": "do not meet the inclusion criteria",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}