{
    "info": {
        "nct_id": "NCT04406831",
        "official_title": "The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer",
        "inclusion_criteria": "* Have biopsy proven adenocarcinoma of the pancreas\n* Have initially inoperable disease, classified as either locally advanced or metastatic disease\n\n  * Recurrent disease after a Whipple procedure is allowed\n  * Patients who are able to undergo resection after neoadjuvant therapy will continue to be followed after resection\n* Have radiographically measurable disease\n* Have an ECOG performance status of 2 or less\n* Be willing to contribute the required information and specimens\n* Provide written signed consent to participate\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Having received prior anti-cancer treatments for metastatic pancreatic cancer\n* Concurrently receiving systemic therapy for another cancer except androgen deprivation therapy for stable/controlled prostate cancer\n* Presence of other active cancer except for: adequately treated local basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of trial. Other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for > 5 years is allowable",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have biopsy proven adenocarcinoma of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "biopsy proven adenocarcinoma of the pancreas",
                    "criterion": "adenocarcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have initially inoperable disease, classified as either locally advanced or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "initially inoperable disease",
                    "criterion": "disease operability",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": "inoperable"
                        }
                    ]
                },
                {
                    "exact_snippets": "classified as either locally advanced or metastatic disease",
                    "criterion": "disease classification",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrent disease after a Whipple procedure is allowed",
            "criterions": [
                {
                    "exact_snippets": "Recurrent disease after a Whipple procedure is allowed",
                    "criterion": "recurrent disease after a Whipple procedure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are able to undergo resection after neoadjuvant therapy will continue to be followed after resection",
            "criterions": [
                {
                    "exact_snippets": "Patients who are able to undergo resection",
                    "criterion": "ability to undergo resection",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after neoadjuvant therapy",
                    "criterion": "completion of neoadjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have radiographically measurable disease",
            "criterions": [
                {
                    "exact_snippets": "radiographically measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "detection_method",
                            "expected_value": "radiographic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have an ECOG performance status of 2 or less",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 2 or less",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be willing to contribute the required information and specimens",
            "criterions": [
                {
                    "exact_snippets": "willing to contribute the required information",
                    "criterion": "willingness to contribute information",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to contribute ... specimens",
                    "criterion": "willingness to contribute specimens",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provide written signed consent to participate",
            "criterions": [
                {
                    "exact_snippets": "Provide written signed consent",
                    "criterion": "consent to participate",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        },
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Having received prior anti-cancer treatments for metastatic pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "Having received prior anti-cancer treatments for metastatic pancreatic cancer",
                    "criterion": "prior anti-cancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrently receiving systemic therapy for another cancer except androgen deprivation therapy for stable/controlled prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Concurrently receiving systemic therapy for another cancer",
                    "criterion": "systemic therapy for another cancer",
                    "requirements": [
                        {
                            "requirement_type": "concurrent receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except androgen deprivation therapy for stable/controlled prostate cancer",
                    "criterion": "androgen deprivation therapy for stable/controlled prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "concurrent receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of other active cancer except for: adequately treated local basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of trial. Other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for > 5 years is allowable",
            "criterions": [
                {
                    "exact_snippets": "Presence of other active cancer",
                    "criterion": "other active cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated local basal or squamous cell carcinoma of the skin",
                    "criterion": "local basal or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic prostate cancer without known metastatic disease",
                    "criterion": "asymptomatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "metastatic disease",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic prostate cancer ... with no requirement for therapy or requiring only hormonal therapy",
                    "criterion": "asymptomatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "therapy requirement",
                            "expected_value": [
                                "none",
                                "hormonal therapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic prostate cancer ... with normal prostate-specific antigen for >1 year prior to start of trial",
                    "criterion": "prostate-specific antigen",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Other adequately treated Stage 1 or 2 cancer currently in complete remission",
                    "criterion": "Stage 1 or 2 cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        },
                        {
                            "requirement_type": "remission status",
                            "expected_value": "complete remission"
                        }
                    ]
                },
                {
                    "exact_snippets": "any other cancer that has been in complete remission for > 5 years",
                    "criterion": "any other cancer",
                    "requirements": [
                        {
                            "requirement_type": "remission duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}