{
    "info": {
        "nct_id": "NCT04854980",
        "official_title": "Serologic Response to the SARS-CoV-2 mRNA-1273 Vaccine in Select Subsets of Oncology Patients - A Pilot Study",
        "inclusion_criteria": "* Subjects are between 50 and 75 years of age;\n* Have not had known or suspected infection with SARS-CoV-2 at any time;\n* Subjects must fall into one of the following subsets of cancer patients:\n\n  * Localized prostate cancer on radiotherapy or have completed radiotherapy in the last three months\n  * Prostate cancer on androgen-deprivation therapy for biochemical recurrence\n  * Colon cancer on adjuvant chemotherapy for stage III disease\n  * CLL on a BTK inhibitor as a first-line single agent for at least 3 months\n  * Melanoma patients on adjuvant immunotherapy with PD-1 checkpoint inhibitors for at least 3 months\n* Have received both doses of SARS-CoV-2 mRNA-1273 vaccine with proof of vaccination or are scheduled to do so;\n* Have at least a one-year life expectancy;\n* Prior radiation therapy is allowed, as long as it was completed more than 6 months prior to vaccination\nMust have minimum age of 50 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Subjects have a known hypersensitivity to a vaccine component;\n* Have had known or suspected infection with SARS-CoV-2 at any time;\n* Are organ transplant recipient on immunosuppression;\n* Had received or are scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post second dose;\n* Had received or are scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post second dose;\n* Received high-dose corticosteroids at any time after receiving the vaccine;\n* Are unable to give informed consent;\n* Are receiving treatment for CLL with another agent (such as rituximab) in addition to a BTK inhibitor",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects are between 50 and 75 years of age;",
            "criterions": [
                {
                    "exact_snippets": "Subjects are between 50 and 75 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have not had known or suspected infection with SARS-CoV-2 at any time;",
            "criterions": [
                {
                    "exact_snippets": "known or suspected infection with SARS-CoV-2",
                    "criterion": "SARS-CoV-2 infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must fall into one of the following subsets of cancer patients:",
            "criterions": [
                {
                    "exact_snippets": "Subjects must fall into one of the following subsets of cancer patients",
                    "criterion": "cancer patient subset",
                    "requirements": [
                        {
                            "requirement_type": "membership",
                            "expected_value": "one of the following subsets"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Localized prostate cancer on radiotherapy or have completed radiotherapy in the last three months",
            "criterions": [
                {
                    "exact_snippets": "Localized prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                },
                {
                    "exact_snippets": "on radiotherapy",
                    "criterion": "radiotherapy status",
                    "requirements": [
                        {
                            "requirement_type": "current treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have completed radiotherapy in the last three months",
                    "criterion": "radiotherapy completion",
                    "requirements": [
                        {
                            "requirement_type": "completion time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate cancer on androgen-deprivation therapy for biochemical recurrence",
            "criterions": [
                {
                    "exact_snippets": "Prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on androgen-deprivation therapy",
                    "criterion": "androgen-deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "current treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biochemical recurrence",
                    "criterion": "biochemical recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Colon cancer on adjuvant chemotherapy for stage III disease",
            "criterions": [
                {
                    "exact_snippets": "Colon cancer",
                    "criterion": "colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant chemotherapy",
                    "criterion": "adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage III disease",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "III"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CLL on a BTK inhibitor as a first-line single agent for at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "CLL",
                    "criterion": "CLL",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "BTK inhibitor",
                    "criterion": "BTK inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "first-line single agent",
                    "criterion": "first-line single agent",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 3 months",
                    "criterion": "treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Melanoma patients on adjuvant immunotherapy with PD-1 checkpoint inhibitors for at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "Melanoma patients",
                    "criterion": "melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant immunotherapy",
                    "criterion": "adjuvant immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PD-1 checkpoint inhibitors",
                    "criterion": "PD-1 checkpoint inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 3 months",
                    "criterion": "duration of treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received both doses of SARS-CoV-2 mRNA-1273 vaccine with proof of vaccination or are scheduled to do so;",
            "criterions": [
                {
                    "exact_snippets": "Have received both doses of SARS-CoV-2 mRNA-1273 vaccine",
                    "criterion": "SARS-CoV-2 mRNA-1273 vaccine doses",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "proof of vaccination",
                    "criterion": "proof of vaccination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are scheduled to do so",
                    "criterion": "scheduled for vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have at least a one-year life expectancy;",
            "criterions": [
                {
                    "exact_snippets": "at least a one-year life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiation therapy is allowed, as long as it was completed more than 6 months prior to vaccination",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation therapy is allowed",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "completed more than 6 months prior to vaccination",
                    "criterion": "time since completion of prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 50 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 50 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Subjects have a known hypersensitivity to a vaccine component;",
            "criterions": [
                {
                    "exact_snippets": "Subjects have a known hypersensitivity to a vaccine component",
                    "criterion": "hypersensitivity to a vaccine component",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have had known or suspected infection with SARS-CoV-2 at any time;",
            "criterions": [
                {
                    "exact_snippets": "known or suspected infection with SARS-CoV-2",
                    "criterion": "SARS-CoV-2 infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are organ transplant recipient on immunosuppression;",
            "criterions": [
                {
                    "exact_snippets": "organ transplant recipient",
                    "criterion": "organ transplant recipient",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on immunosuppression",
                    "criterion": "immunosuppression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had received or are scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post second dose;",
            "criterions": [
                {
                    "exact_snippets": "Had received or are scheduled to receive a live virus vaccine",
                    "criterion": "live virus vaccine",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "4 weeks prior to Dose 1 through 28 days post second dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had received or are scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post second dose;",
            "criterions": [
                {
                    "exact_snippets": "Had received or are scheduled to receive an inactivated vaccine",
                    "criterion": "inactivated vaccine administration",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "in the period ranging from 7 days prior to Dose 1 through 7 days post second dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received high-dose corticosteroids at any time after receiving the vaccine;",
            "criterions": [
                {
                    "exact_snippets": "Received high-dose corticosteroids",
                    "criterion": "high-dose corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after receiving the vaccine",
                    "criterion": "vaccine receipt",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "before high-dose corticosteroids"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are unable to give informed consent;",
            "criterions": [
                {
                    "exact_snippets": "unable to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are receiving treatment for CLL with another agent (such as rituximab) in addition to a BTK inhibitor",
            "criterions": [
                {
                    "exact_snippets": "receiving treatment for CLL",
                    "criterion": "treatment for CLL",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "another agent (such as rituximab)",
                    "criterion": "treatment with another agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in addition to a BTK inhibitor",
                    "criterion": "treatment with BTK inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}