{
    "info": {
        "nct_id": "NCT04736472",
        "official_title": "Implementing Pharmacogenetic Testing in Gastrointestinal Cancers",
        "inclusion_criteria": "1. Able and willing to provide informed consent\n2. Male or female, aged 18 years or older at the time of study initiation\n3. Pathologically confirmed gastrointestinal malignancy for which treatment with a fluoropyrimidine and/or irinotecan is indicated\n4. Willing to undergo blood or saliva sampling for PGx testing and comply with all study-related procedures\n5. Life expectancy of at least 6 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Prior treatment with irinotecan\n2. DPYD or UGT1A1 genotype already known\n3. Severe renal or hepatic impairment (or unacceptable laboratory values), including:\n\n   * Neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L\n   * Hepatic function as defined by serum bilirubin >1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) >2.5 x ULN, or in case of liver metastases ALT and AST>5 x ULN\n   * Renal function as defined by serum creatinine >1.5 x ULN, or creatinine clearance <60 ml/min (by Cockcroft-Gault Equation)\n4. Women who are pregnant or breast feeding, or subjects who refuse to use reliable contraceptive methods throughout the study\n5. Treating physician does not want subject to participate",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Able and willing to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male or female, aged 18 years or older at the time of study initiation",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pathologically confirmed gastrointestinal malignancy for which treatment with a fluoropyrimidine and/or irinotecan is indicated",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed gastrointestinal malignancy",
                    "criterion": "gastrointestinal malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with a fluoropyrimidine and/or irinotecan is indicated",
                    "criterion": "treatment indication",
                    "requirements": [
                        {
                            "requirement_type": "medications",
                            "expected_value": [
                                "fluoropyrimidine",
                                "irinotecan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Willing to undergo blood or saliva sampling for PGx testing and comply with all study-related procedures",
            "criterions": [
                {
                    "exact_snippets": "Willing to undergo blood or saliva sampling for PGx testing",
                    "criterion": "willingness to undergo sampling",
                    "requirements": [
                        {
                            "requirement_type": "type of sampling",
                            "expected_value": [
                                "blood",
                                "saliva"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "comply with all study-related procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Life expectancy of at least 6 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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. Prior treatment with irinotecan",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with irinotecan",
                    "criterion": "irinotecan treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. DPYD or UGT1A1 genotype already known",
            "criterions": [
                {
                    "exact_snippets": "DPYD ... genotype already known",
                    "criterion": "DPYD genotype",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "UGT1A1 genotype already known",
                    "criterion": "UGT1A1 genotype",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Severe renal or hepatic impairment (or unacceptable laboratory values), including:",
            "criterions": [
                {
                    "exact_snippets": "Severe renal ... impairment",
                    "criterion": "renal impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe ... hepatic impairment",
                    "criterion": "hepatic impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "unacceptable laboratory values",
                    "criterion": "laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil count of <1.5 x 109/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count of <100 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatic function as defined by serum bilirubin >1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) >2.5 x ULN, or in case of liver metastases ALT and AST>5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "serum bilirubin >1.5 x upper limit of normal (ULN)",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... >2.5 x ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) >2.5 x ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "liver metastases ALT and AST>5 x ULN",
                    "criterion": "alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in case of liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal function as defined by serum creatinine >1.5 x ULN, or creatinine clearance <60 ml/min (by Cockcroft-Gault Equation)",
            "criterions": [
                {
                    "exact_snippets": "Renal function as defined by serum creatinine >1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance <60 ml/min (by Cockcroft-Gault Equation)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Women who are pregnant or breast feeding, or subjects who refuse to use reliable contraceptive methods throughout the study",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "refuse to use reliable contraceptive methods",
                    "criterion": "use of reliable contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Treating physician does not want subject to participate",
            "criterions": [
                {
                    "exact_snippets": "Treating physician does not want subject to participate",
                    "criterion": "treating physician's decision",
                    "requirements": [
                        {
                            "requirement_type": "decision",
                            "expected_value": "does not want subject to participate"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}