[96a5a0]: / output / allTrials / identified / NCT04211727_identified.json

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{
"info": {
"nct_id": "NCT04211727",
"official_title": "Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System",
"inclusion_criteria": "* Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle\n* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care\n* Can provide written informed consent\n* Cohort 2 only- Able to independently complete participant questionnaires\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Receiving systemic anti-cancer therapy for a haematological malignancy\n* Known parasitic infection\n* Known inherited or acquired bleeding disorder\n* History of haematological malignancy\n* Known poorly controlled anti-coagulation\n* Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle",
"criterions": [
{
"exact_snippets": "Age >18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "Currently receiving standard of care systemic anti-cancer therapy",
"criterion": "systemic anti-cancer therapy",
"requirements": [
{
"requirement_type": "status",
"expected_value": "currently receiving"
}
]
},
{
"exact_snippets": "solid organ malignancy",
"criterion": "solid organ malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "has received at least one cycle",
"criterion": "anti-cancer therapy cycle",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cycle"
}
}
]
}
]
},
{
"line": "* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care",
"criterions": [
{
"exact_snippets": "Scheduled to be undergoing routine venous laboratory blood tests",
"criterion": "venous laboratory blood tests",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": true
}
]
}
]
},
{
"line": "* Can provide written informed consent",
"criterions": [
{
"exact_snippets": "Can provide written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Cohort 2 only- Able to independently complete participant questionnaires",
"criterions": [
{
"exact_snippets": "Able to independently complete participant questionnaires",
"criterion": "ability to complete participant questionnaires",
"requirements": [
{
"requirement_type": "independence",
"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": "* Receiving systemic anti-cancer therapy for a haematological malignancy",
"criterions": [
{
"exact_snippets": "Receiving systemic anti-cancer therapy",
"criterion": "systemic anti-cancer therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "haematological malignancy",
"criterion": "haematological malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Known parasitic infection",
"criterions": [
{
"exact_snippets": "Known parasitic infection",
"criterion": "parasitic infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Known inherited or acquired bleeding disorder",
"criterions": [
{
"exact_snippets": "Known inherited or acquired bleeding disorder",
"criterion": "bleeding disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
},
{
"requirement_type": "inheritance",
"expected_value": [
"inherited",
"acquired"
]
}
]
}
]
},
{
"line": "* History of haematological malignancy",
"criterions": [
{
"exact_snippets": "History of haematological malignancy",
"criterion": "haematological malignancy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Known poorly controlled anti-coagulation",
"criterions": [
{
"exact_snippets": "Known poorly controlled anti-coagulation",
"criterion": "anti-coagulation",
"requirements": [
{
"requirement_type": "control",
"expected_value": "poorly controlled"
}
]
}
]
},
{
"line": "* Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result",
"criterions": [
{
"exact_snippets": "Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result",
"criterion": "ability to perform fine manipulation",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}