{
"info": {
"nct_id": "NCT06167460",
"official_title": "Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer",
"inclusion_criteria": "* Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.\n* FFPE/FNA sample is available.\n* Compliant with treatment protocol.\n* Patients consented to participate in the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Patients already started TKI before enrollment.\n* Patients already started chemotherapy before enrollment.\n* Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.\n* Patients did not agree to participate in the studies.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.",
"criterions": [
{
"exact_snippets": "diagnosed with advanced non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
},
{
"exact_snippets": "indicated for TKI (first or second line)",
"criterion": "TKI indication",
"requirement": {
"requirement_type": "line of therapy",
"expected_value": [
"first",
"second"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "diagnosed with advanced non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
},
{
"exact_snippets": "indicated for TKI (first or second line)",
"criterion": "TKI indication",
"requirement": {
"requirement_type": "line of therapy",
"expected_value": [
"first",
"second"
]
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "indicated for TKI (first or second line)",
"criterion": "TKI indication",
"requirement": {
"requirement_type": "line of therapy",
"expected_value": [
"first",
"second"
]
}
},
{
"exact_snippets": "TKI combined with chemotherapy is allowed",
"criterion": "TKI combined with chemotherapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* FFPE/FNA sample is available.",
"criterions": [
{
"exact_snippets": "FFPE/FNA sample is available",
"criterion": "FFPE/FNA sample",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "FFPE/FNA sample is available",
"criterion": "FFPE/FNA sample",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Compliant with treatment protocol.",
"criterions": [
{
"exact_snippets": "Compliant with treatment protocol",
"criterion": "treatment protocol compliance",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Compliant with treatment protocol",
"criterion": "treatment protocol compliance",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients consented to participate in the study.",
"criterions": [
{
"exact_snippets": "Patients consented to participate in the study.",
"criterion": "consent to participate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients consented to participate in the study.",
"criterion": "consent to participate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients already started TKI before enrollment.",
"criterions": [
{
"exact_snippets": "Patients already started TKI before enrollment.",
"criterion": "TKI treatment",
"requirement": {
"requirement_type": "status",
"expected_value": "started before enrollment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients already started TKI before enrollment.",
"criterion": "TKI treatment",
"requirement": {
"requirement_type": "status",
"expected_value": "started before enrollment"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients already started chemotherapy before enrollment.",
"criterions": [
{
"exact_snippets": "Patients already started chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "status",
"expected_value": "started"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients already started chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "status",
"expected_value": "started"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients did not agree to participate in the studies.",
"criterions": [
{
"exact_snippets": "Patients did not agree to participate",
"criterion": "agreement to participate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients did not agree to participate",
"criterion": "agreement to participate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.",
"criterions": [
{
"exact_snippets": "Medical or psychiatric conditions",
"criterion": "medical or psychiatric conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "occupational responsibilities",
"criterion": "occupational responsibilities",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Medical or psychiatric conditions",
"criterion": "medical or psychiatric conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "occupational responsibilities",
"criterion": "occupational responsibilities",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}