{
"info": {
"nct_id": "NCT05834348",
"official_title": "Drug Treatment Patterns and Effects for Metastatic Non-small Cell Lung Cancer Patients In NORway (DELINOR)",
"inclusion_criteria": "1. Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis\n2. Received their first NSCLC diagnosis (stage IIIb, IIIc, IVa, or IVb) between 01 January 2009, and latest available year\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis who received radiation therapy with curative intent, defined as a radiation dose larger than 50gy\n2. If the data include patients diagnosed after 2021, IIIb patients will be excluded due to changes in the guideline. The updated guidelines for 2022 recommends that patients diagnosed with stage IIIb who have surgery with the intent to cure should not have ''curative'' radiation (i.e.: it is not possible to exclude these from the population from 2022).",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis",
"criterions": [
{
"exact_snippets": "Patients ≥ 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "histologically confirmed",
"criterion": "NSCLC confirmation method",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically"
}
]
},
{
"exact_snippets": "stage IIIb, IIIc, IVa, or IVb NSCLC",
"criterion": "NSCLC stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"IIIb",
"IIIc",
"IVa",
"IVb"
]
}
]
}
]
},
{
"line": "2. Received their first NSCLC diagnosis (stage IIIb, IIIc, IVa, or IVb) between 01 January 2009, and latest available year",
"criterions": [
{
"exact_snippets": "first NSCLC diagnosis",
"criterion": "NSCLC diagnosis",
"requirements": [
{
"requirement_type": "order",
"expected_value": "first"
}
]
},
{
"exact_snippets": "stage IIIb, IIIc, IVa, or IVb",
"criterion": "NSCLC stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"IIIb",
"IIIc",
"IVa",
"IVb"
]
}
]
},
{
"exact_snippets": "between 01 January 2009, and latest available year",
"criterion": "diagnosis date",
"requirements": [
{
"requirement_type": "date range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2009,
"unit": "year"
},
{
"operator": "<=",
"value": 2023,
"unit": "year"
}
]
}
}
]
}
]
},
{
"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": "1. Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis who received radiation therapy with curative intent, defined as a radiation dose larger than 50gy",
"criterions": [
{
"exact_snippets": "Patients ≥ 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC",
"criterion": "NSCLC stage",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
},
{
"requirement_type": "stages",
"expected_value": [
"IIIb",
"IIIc",
"IVa",
"IVb"
]
}
]
},
{
"exact_snippets": "received radiation therapy with curative intent",
"criterion": "radiation therapy intent",
"requirements": [
{
"requirement_type": "intent",
"expected_value": "curative"
}
]
},
{
"exact_snippets": "radiation dose larger than 50gy",
"criterion": "radiation dose",
"requirements": [
{
"requirement_type": "minimum dose",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "gy"
}
}
]
}
]
},
{
"line": "2. If the data include patients diagnosed after 2021, IIIb patients will be excluded due to changes in the guideline. The updated guidelines for 2022 recommends that patients diagnosed with stage IIIb who have surgery with the intent to cure should not have ''curative'' radiation (i.e.: it is not possible to exclude these from the population from 2022).",
"criterions": [
{
"exact_snippets": "patients diagnosed after 2021",
"criterion": "diagnosis year",
"requirements": [
{
"requirement_type": "year",
"expected_value": {
"operator": ">",
"value": 2021,
"unit": "year"
}
}
]
},
{
"exact_snippets": "IIIb patients will be excluded",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "IIIb"
}
]
},
{
"exact_snippets": "patients diagnosed with stage IIIb who have surgery with the intent to cure",
"criterion": "surgery intent",
"requirements": [
{
"requirement_type": "intent",
"expected_value": "curative"
}
]
},
{
"exact_snippets": "patients diagnosed with stage IIIb who have surgery with the intent to cure should not have ''curative'' radiation",
"criterion": "radiation intent",
"requirements": [
{
"requirement_type": "intent",
"expected_value": "curative"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}