{
"info": {
"nct_id": "NCT06281691",
"official_title": "GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit",
"inclusion_criteria": "* ≥18 years of age at the time of signing the Informed Consent Form with an indication for cystoscopy and planned for this already at study inclusion.\n* Ability to understand the Participant Information Sheet orally and in writing in either Danish or Greenlandic.\n* Signed Informed Consent Form.\n* Is, according to the Investigator's judgement, able to comply with the trial protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients not willing to participate.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* ≥18 years of age at the time of signing the Informed Consent Form with an indication for cystoscopy and planned for this already at study inclusion.",
"criterions": [
{
"exact_snippets": "≥18 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "indication for cystoscopy",
"criterion": "indication for cystoscopy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "planned for this already at study inclusion",
"criterion": "cystoscopy planning",
"requirements": [
{
"requirement_type": "planned",
"expected_value": true
}
]
}
]
},
{
"line": "* Ability to understand the Participant Information Sheet orally and in writing in either Danish or Greenlandic.",
"criterions": [
{
"exact_snippets": "Ability to understand the Participant Information Sheet orally and in writing",
"criterion": "understanding of Participant Information Sheet",
"requirements": [
{
"requirement_type": "mode",
"expected_value": [
"orally",
"in writing"
]
}
]
},
{
"exact_snippets": "in either Danish or Greenlandic",
"criterion": "language of understanding",
"requirements": [
{
"requirement_type": "language",
"expected_value": [
"Danish",
"Greenlandic"
]
}
]
}
]
},
{
"line": "* Signed Informed Consent Form.",
"criterions": [
{
"exact_snippets": "Signed Informed Consent Form",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"line": "* Is, according to the Investigator's judgement, able to comply with the trial protocol.",
"criterions": [
{
"exact_snippets": "able to comply with the trial protocol",
"criterion": "compliance with trial protocol",
"requirements": [
{
"requirement_type": "ability",
"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": "* Patients not willing to participate.",
"criterions": [
{
"exact_snippets": "Patients not willing to participate",
"criterion": "willingness to participate",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}