{
    "info": {
        "nct_id": "NCT02443948",
        "official_title": "Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST): Detection and Correlation With Disease Status Assessed by Conventional Technique. Prospective Observational Study",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Impossibility to ensure adequate clinical and serum sample follow-up\n* Serious psychiatric disease that precludes informed consent or limits compliance",
        "miscellaneous_criteria": "* Male or female patients aged >= 18 years\n* Histologically confirmed diagnosis of GIST of any anatomical location either by biopsy or surgical specimen\n* Available archival tumor tissue\n* Signed informed consent form"
    },
    "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 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": "* Impossibility to ensure adequate clinical and serum sample follow-up",
            "criterions": [
                {
                    "exact_snippets": "adequate clinical and serum sample follow-up",
                    "criterion": "clinical and serum sample follow-up",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious psychiatric disease that precludes informed consent or limits compliance",
            "criterions": [
                {
                    "exact_snippets": "Serious psychiatric disease",
                    "criterion": "psychiatric disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "precludes informed consent",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "limits compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "* Male or female patients aged >= 18 years",
            "criterions": [
                {
                    "exact_snippets": "Male or female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged >= 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed diagnosis of GIST of any anatomical location either by biopsy or surgical specimen",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of GIST",
                    "criterion": "GIST diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "GIST of any anatomical location",
                    "criterion": "GIST anatomical location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "either by biopsy or surgical specimen",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "biopsy",
                                "surgical specimen"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Available archival tumor tissue",
            "criterions": [
                {
                    "exact_snippets": "Available archival tumor tissue",
                    "criterion": "archival tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent form",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}