{
    "info": {
        "nct_id": "NCT03480776",
        "official_title": "A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women With BRCA 1/2 Mutations (STICs and STONEs)",
        "inclusion_criteria": "* Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines\n* Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) scheduled for within 6 months to 2 years after the date of randomization as standard of care, for women who have completed their families\n* ECOG performance status 0 or 1\n* Age ≥ 18 years old\n* Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French.\n* Subject consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each subject must sign a consent form prior to enrollment in the trial to document their willingness to participate\n* Subjects must be accessible for treatment and follow up. Subjects randomized on this trial must be treated and followed at the participating centre.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization\n* Women of childbearing potential must have agreed to use a highly effective contraceptive method for the duration of the study treatment and for 30 days post last dose of study medication\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects with history of other malignancies, except:\n\n  * adequately treated non-melanoma skin cancer;\n  * curatively treated in-situ cancer of the cervix;\n  * previously diagnosed (at any point) breast cancer, treated with curative intent; prior chemotherapy is allowed and the last dose must be ≥ 12 months prior to randomization; endocrine therapy for breast cancer is allowed at any time.\n  * other solid tumours curatively treated with no evidence of disease for > 5 years.\n* Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time.\n* Subjects with active bleeding or bleeding diathesis.\n* Subjects with active peptic ulcer.\n* Subjects with renal, hepatic or congestive heart failure.\n* Subjects with concurrent use of anti-coagulants and/or anti-platelet agents.\n* Subjects with prior bilateral salpingectomy.\n* Subjects with history of chronic daily use of ASA or NSAIDs.\n* Subjects with intolerance of ASA including subjects with a history of asthma induced by salicylates or substances with a similar action, notably non-steroidal-anti-inflammatory drugs.\n* Ongoing or planned pregnancy.\n* Subjects who are breastfeeding.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines",
            "criterions": [
                {
                    "exact_snippets": "Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant",
                    "criterion": "germline BRCA1/2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "based on the ACMG 2015 guidelines",
                    "criterion": "ACMG 2015 guidelines",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) scheduled for within 6 months to 2 years after the date of randomization as standard of care, for women who have completed their families",
            "criterions": [
                {
                    "exact_snippets": "Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria)",
                    "criterion": "risk-reducing surgery",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "bilateral salpingo-oophorectomy",
                                "bilateral salpingectomy inclusive of fimbria"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled for within 6 months to 2 years after the date of randomization",
                    "criterion": "surgery schedule",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "for women who have completed their families",
                    "criterion": "family completion",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French.",
            "criterions": [
                {
                    "exact_snippets": "Subject is able (i.e. sufficiently literate) ... complete the Credibility/Expectancy questionnaire",
                    "criterion": "literacy",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject is ... willing to complete the Credibility/Expectancy questionnaire",
                    "criterion": "willingness to complete questionnaire",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complete the Credibility/Expectancy questionnaire in English or French",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "languages",
                            "expected_value": [
                                "English",
                                "French"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each subject must sign a consent form prior to enrollment in the trial to document their willingness to participate",
            "criterions": [
                {
                    "exact_snippets": "Subject consent must be appropriately obtained ... Each subject must sign a consent form",
                    "criterion": "subject consent",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "in accordance with applicable local and regulatory requirements"
                        },
                        {
                            "requirement_type": "documentation",
                            "expected_value": "signed consent form"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must be accessible for treatment and follow up. Subjects randomized on this trial must be treated and followed at the participating centre.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must be accessible for treatment and follow up.",
                    "criterion": "accessibility for treatment and follow up",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects randomized on this trial must be treated and followed at the participating centre.",
                    "criterion": "treatment and follow up location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "participating centre"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization",
            "criterions": [
                {
                    "exact_snippets": "protocol treatment is to begin within 2 working days after subject randomization",
                    "criterion": "protocol treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "working days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must have agreed to use a highly effective contraceptive method for the duration of the study treatment and for 30 days post last dose of study medication",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have agreed to use a highly effective contraceptive method",
                    "criterion": "use of contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the duration of the study treatment and for 30 days post last dose of study medication",
                    "criterion": "duration of contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of the study treatment and for 30 days post last dose of study medication"
                        }
                    ]
                }
            ]
        },
        {
            "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": [
        {
            "line": "* Subjects with history of other malignancies, except:",
            "criterions": [
                {
                    "exact_snippets": "history of other malignancies",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* adequately treated non-melanoma skin cancer;",
            "criterions": [
                {
                    "exact_snippets": "adequately treated non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* curatively treated in-situ cancer of the cervix;",
            "criterions": [
                {
                    "exact_snippets": "curatively treated in-situ cancer of the cervix",
                    "criterion": "in-situ cancer of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* previously diagnosed (at any point) breast cancer, treated with curative intent; prior chemotherapy is allowed and the last dose must be ≥ 12 months prior to randomization; endocrine therapy for breast cancer is allowed at any time.",
            "criterions": [
                {
                    "exact_snippets": "previously diagnosed (at any point) breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with curative intent",
                    "criterion": "treatment intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior chemotherapy is allowed ... last dose must be ≥ 12 months prior to randomization",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "endocrine therapy for breast cancer is allowed at any time",
                    "criterion": "endocrine therapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "any time"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* other solid tumours curatively treated with no evidence of disease for > 5 years.",
            "criterions": [
                {
                    "exact_snippets": "other solid tumours curatively treated",
                    "criterion": "solid tumours",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of disease",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "for > 5 years",
                    "criterion": "disease-free period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have been treated with any PARP-inhibitors (e.g. olaparib)",
                    "criterion": "treatment with PARP-inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with active bleeding or bleeding diathesis.",
            "criterions": [
                {
                    "exact_snippets": "active bleeding",
                    "criterion": "bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with active peptic ulcer.",
            "criterions": [
                {
                    "exact_snippets": "active peptic ulcer",
                    "criterion": "peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with renal, hepatic or congestive heart failure.",
            "criterions": [
                {
                    "exact_snippets": "renal",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatic",
                    "criterion": "hepatic failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with concurrent use of anti-coagulants and/or anti-platelet agents.",
            "criterions": [
                {
                    "exact_snippets": "concurrent use of anti-coagulants",
                    "criterion": "anti-coagulant use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrent use of ... anti-platelet agents",
                    "criterion": "anti-platelet agent use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with prior bilateral salpingectomy.",
            "criterions": [
                {
                    "exact_snippets": "prior bilateral salpingectomy",
                    "criterion": "bilateral salpingectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with history of chronic daily use of ASA or NSAIDs.",
            "criterions": [
                {
                    "exact_snippets": "history of chronic daily use of ASA or NSAIDs",
                    "criterion": "chronic daily use of ASA or NSAIDs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with intolerance of ASA including subjects with a history of asthma induced by salicylates or substances with a similar action, notably non-steroidal-anti-inflammatory drugs.",
            "criterions": [
                {
                    "exact_snippets": "intolerance of ASA",
                    "criterion": "ASA intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of asthma induced by salicylates",
                    "criterion": "asthma induced by salicylates",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "substances with a similar action, notably non-steroidal-anti-inflammatory drugs",
                    "criterion": "intolerance to non-steroidal anti-inflammatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing or planned pregnancy.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing or planned pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "planned"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who are breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are breastfeeding.",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}