{
    "info": {
        "nct_id": "NCT03749720",
        "official_title": "Can Digital Droplet PCR (ddPCR) on Blood Samples From Patients With HPV Related Cancers Become a Reality in Cancer Treatment and Monitoring?",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria cases:\n\n* Diagnosed with cervical cancer ≥ stage 1B between june 2018 and june 2020\n* > 18 years of age at the time of diagnosis\n* There must be available cervical tissue material from the patient to analyse for HPV\n\nInclusion Criteria healthy controls\n\n* Women > 18 years with no prior history of any cervical dysplasia\n\nInclusion Criteria CIN3 controls\n\n* Women > 18 years\n* Must have a histologically verified severe cervical dysplasia (CIN3)\n* Is admitted for cervical conisation\n\nExclusion Criteria cases:\n\n* < 18 years of age at time of cervical cancer diagnosis\n* Cervical cancer < stage 1B\n\nExclusion Criteria healthy controls:\n\n* < 18 years of age\n* Prior cervical dysplasia\n\nExclusion Criteria CIN3 controls:\n\n* < 18 years of age\n* Women with only low grades of cervical dysplasia (CIN1 or CIN2)\n* Women with HPV-negative cervical biopsies"
    },
    "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Diagnosed with cervical cancer ≥ stage 1B between june 2018 and june 2020",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with cervical cancer",
                    "criterion": "cervical cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ stage 1B",
                    "criterion": "cervical cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "B"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "between june 2018 and june 2020",
                    "criterion": "diagnosis date",
                    "requirements": [
                        {
                            "requirement_type": "date range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2018,
                                        "unit": "year"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2020,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* > 18 years of age at the time of diagnosis",
            "criterions": [
                {
                    "exact_snippets": "> 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* There must be available cervical tissue material from the patient to analyse for HPV",
            "criterions": [
                {
                    "exact_snippets": "available cervical tissue material",
                    "criterion": "cervical tissue material",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "analyse for HPV",
                    "criterion": "HPV analysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Inclusion Criteria healthy controls",
            "criterions": [
                {
                    "exact_snippets": "healthy controls",
                    "criterion": "health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women > 18 years with no prior history of any cervical dysplasia",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "> 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no prior history of any cervical dysplasia",
                    "criterion": "cervical dysplasia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Inclusion Criteria CIN3 controls",
            "criterions": [
                {
                    "exact_snippets": "CIN3 controls",
                    "criterion": "CIN3",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women > 18 years",
            "criterions": [
                {
                    "exact_snippets": "Women > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have a histologically verified severe cervical dysplasia (CIN3)",
            "criterions": [
                {
                    "exact_snippets": "Must have a histologically verified severe cervical dysplasia (CIN3)",
                    "criterion": "cervical dysplasia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "verification",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "classification",
                            "expected_value": "CIN3"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is admitted for cervical conisation",
            "criterions": [
                {
                    "exact_snippets": "admitted for cervical conisation",
                    "criterion": "cervical conisation",
                    "requirements": [
                        {
                            "requirement_type": "admission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 18 years of age at time of cervical cancer diagnosis",
            "criterions": [
                {
                    "exact_snippets": "< 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical cancer diagnosis",
                    "criterion": "cervical cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cervical cancer < stage 1B",
            "criterions": [
                {
                    "exact_snippets": "Cervical cancer < stage 1B",
                    "criterion": "cervical cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "B"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Exclusion Criteria healthy controls:",
            "criterions": [
                {
                    "exact_snippets": "healthy controls",
                    "criterion": "health status",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "< 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior cervical dysplasia",
            "criterions": [
                {
                    "exact_snippets": "Prior cervical dysplasia",
                    "criterion": "cervical dysplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Exclusion Criteria CIN3 controls:",
            "criterions": [
                {
                    "exact_snippets": "CIN3 controls",
                    "criterion": "CIN3",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "< 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women with only low grades of cervical dysplasia (CIN1 or CIN2)",
            "criterions": [
                {
                    "exact_snippets": "low grades of cervical dysplasia (CIN1 or CIN2)",
                    "criterion": "cervical dysplasia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "CIN1",
                                "CIN2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women with HPV-negative cervical biopsies",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "HPV-negative cervical biopsies",
                    "criterion": "HPV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria cases:",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria cases:",
            "criterions": []
        }
    ]
}