{
    "info": {
        "nct_id": "NCT03976973",
        "official_title": "A Phase 2, Multi-centre Study of BromAc for Recurrent Peritoneal Mucinous Tumour or Pseudomyxoma Peritonei",
        "inclusion_criteria": "* Aged 18 - 80 years\n* Have a mucinous tumour/pseudomyxoma peritonei target lesion with a defined cavity, with the shortest diameter being at least 3 centimeters on radiology, and percutaneously accessible. In the case of a target lesion, tumour located at distant sites (for e.g. pleura) will not exclude a patient from this study and these tumours may be treated, if suitable, under expanded access protocols.\n* Are symptomatic or at risk of becoming symptomatic or obstructed imminently, are considered inoperable, at high risk of morbidity, mortality or quality of life decline for repeat surgery, or do not wish to explore repeat surgery\n* Are considered suitable for the trial based on a multidisciplinary team meeting case review\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Have a non-mucinous tumour (hard caked tumour) that does not have cystic appearance on radiology. Having a hard tumour appearance in one region does not exclude treatment in another area, provided the appearance is mucinous.\n* Have suspected fistula of the tumour into the gastrointestinal tract, invading or abutting major vessel or other area of concern (fistulation into bladder or vaginal cuff is not an exclusion for treatment)\n* Have known allergy (anaphylaxis) or allergy to pineapples, papain, bromeliads, sulphur, eggs or Acetylcysteine or any other serious allergy or intolerance to fruits or food products\n* Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy that cannot be managed or withheld for the radiology procedure\n* Have an infected tumour or ongoing inflammatory process (pus on aspiration at radiology will be a delayed failure) as indicated on baseline blood test\n* Eastern Cooperative Oncology Group (ECOG) score >2\n* Have had chemotherapy within the last two weeks, have not had bone marrow recovery from chemotherapy, or had Bevacizumab (Avastin) within the last 4 weeks. A staging baseline scan must be completed prior to considering entry into this study.\n* Have previously received BromAc for pseudomyxoma or peritoneal mucinous tumour (see expanded access)\n* Have other serious comorbidities where inclusion in the trial will subject the participant to an unacceptable higher risk of adverse events as judged by the investigator\n* Pregnant women are excluded from this study because BromAc has unknown but a potential risk for adverse events in nursing infants secondary to treatment of the mother\n* Participants with psychiatric illness/social situations that would limit compliance with study requirements\n* Are unable to give fully informed and educated consent or are unable to comply with the standard follow up procedures of a clinical trial",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Aged 18 - 80 years",
            "criterions": [
                {
                    "exact_snippets": "Aged 18 - 80 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a mucinous tumour/pseudomyxoma peritonei target lesion with a defined cavity, with the shortest diameter being at least 3 centimeters on radiology, and percutaneously accessible. In the case of a target lesion, tumour located at distant sites (for e.g. pleura) will not exclude a patient from this study and these tumours may be treated, if suitable, under expanded access protocols.",
            "criterions": [
                {
                    "exact_snippets": "mucinous tumour/pseudomyxoma peritonei target lesion",
                    "criterion": "tumour type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "mucinous tumour",
                                "pseudomyxoma peritonei"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "defined cavity",
                    "criterion": "target lesion cavity",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "defined"
                        }
                    ]
                },
                {
                    "exact_snippets": "shortest diameter being at least 3 centimeters on radiology",
                    "criterion": "target lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "centimeters"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "percutaneously accessible",
                    "criterion": "target lesion accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": "percutaneously accessible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are symptomatic or at risk of becoming symptomatic or obstructed imminently, are considered inoperable, at high risk of morbidity, mortality or quality of life decline for repeat surgery, or do not wish to explore repeat surgery",
            "criterions": [
                {
                    "exact_snippets": "Are symptomatic",
                    "criterion": "symptomatic",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at risk of becoming symptomatic",
                    "criterion": "risk of becoming symptomatic",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at risk of becoming ... obstructed imminently",
                    "criterion": "risk of imminent obstruction",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered inoperable",
                    "criterion": "inoperable",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at high risk of morbidity",
                    "criterion": "risk of morbidity",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "at high risk of ... mortality",
                    "criterion": "risk of mortality",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "at high risk of ... quality of life decline",
                    "criterion": "risk of quality of life decline",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "do not wish to explore repeat surgery",
                    "criterion": "willingness to explore repeat surgery",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are considered suitable for the trial based on a multidisciplinary team meeting case review",
            "criterions": [
                {
                    "exact_snippets": "suitable for the trial based on a multidisciplinary team meeting case review",
                    "criterion": "suitability for the trial",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "multidisciplinary team meeting case review"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Have a non-mucinous tumour (hard caked tumour) that does not have cystic appearance on radiology. Having a hard tumour appearance in one region does not exclude treatment in another area, provided the appearance is mucinous.",
            "criterions": [
                {
                    "exact_snippets": "non-mucinous tumour",
                    "criterion": "tumour type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-mucinous"
                        }
                    ]
                },
                {
                    "exact_snippets": "hard caked tumour",
                    "criterion": "tumour consistency",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": "hard caked"
                        }
                    ]
                },
                {
                    "exact_snippets": "does not have cystic appearance on radiology",
                    "criterion": "tumour appearance on radiology",
                    "requirements": [
                        {
                            "requirement_type": "appearance",
                            "expected_value": "non-cystic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have suspected fistula of the tumour into the gastrointestinal tract, invading or abutting major vessel or other area of concern (fistulation into bladder or vaginal cuff is not an exclusion for treatment)",
            "criterions": [
                {
                    "exact_snippets": "suspected fistula of the tumour into the gastrointestinal tract",
                    "criterion": "fistula of the tumour into the gastrointestinal tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "invading or abutting major vessel",
                    "criterion": "tumour invading or abutting major vessel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other area of concern",
                    "criterion": "tumour invading or abutting other area of concern",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have known allergy (anaphylaxis) or allergy to pineapples, papain, bromeliads, sulphur, eggs or Acetylcysteine or any other serious allergy or intolerance to fruits or food products",
            "criterions": [
                {
                    "exact_snippets": "known allergy (anaphylaxis) or allergy to pineapples, papain, bromeliads, sulphur, eggs or Acetylcysteine",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serious allergy or intolerance to fruits or food products",
                    "criterion": "serious allergy or intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy that cannot be managed or withheld for the radiology procedure",
            "criterions": [
                {
                    "exact_snippets": "Have a coagulation disorder of any kind",
                    "criterion": "coagulation disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are on anticoagulant or anti-platelet therapy",
                    "criterion": "anticoagulant or anti-platelet therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have an infected tumour or ongoing inflammatory process (pus on aspiration at radiology will be a delayed failure) as indicated on baseline blood test",
            "criterions": [
                {
                    "exact_snippets": "Have an infected tumour",
                    "criterion": "infected tumour",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing inflammatory process",
                    "criterion": "inflammatory process",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pus on aspiration at radiology",
                    "criterion": "pus on aspiration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) score >2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score >2",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have had chemotherapy within the last two weeks, have not had bone marrow recovery from chemotherapy, or had Bevacizumab (Avastin) within the last 4 weeks. A staging baseline scan must be completed prior to considering entry into this study.",
            "criterions": [
                {
                    "exact_snippets": "Have had chemotherapy within the last two weeks",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have not had bone marrow recovery from chemotherapy",
                    "criterion": "bone marrow recovery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had Bevacizumab (Avastin) within the last 4 weeks",
                    "criterion": "Bevacizumab (Avastin)",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "A staging baseline scan must be completed",
                    "criterion": "staging baseline scan",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have previously received BromAc for pseudomyxoma or peritoneal mucinous tumour (see expanded access)",
            "criterions": [
                {
                    "exact_snippets": "Have previously received BromAc",
                    "criterion": "BromAc treatment history",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pseudomyxoma",
                    "criterion": "pseudomyxoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peritoneal mucinous tumour",
                    "criterion": "peritoneal mucinous tumour",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have other serious comorbidities where inclusion in the trial will subject the participant to an unacceptable higher risk of adverse events as judged by the investigator",
            "criterions": [
                {
                    "exact_snippets": "Have other serious comorbidities",
                    "criterion": "serious comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women are excluded from this study because BromAc has unknown but a potential risk for adverse events in nursing infants secondary to treatment of the mother",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with psychiatric illness/social situations that would limit compliance with study requirements",
            "criterions": [
                {
                    "exact_snippets": "psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "social situations that would limit compliance with study requirements",
                    "criterion": "social situations limiting compliance",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are unable to give fully informed and educated consent or are unable to comply with the standard follow up procedures of a clinical trial",
            "criterions": [
                {
                    "exact_snippets": "unable to give fully informed and educated consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to comply with the standard follow up procedures",
                    "criterion": "compliance with follow up procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}