{
"info": {
"nct_id": "NCT06585501",
"official_title": "Treatment and Testing Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China: A Retrospective Real-world Study (REHEARSAL)",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion criteria\n\n* Patients with pathologically diagnosed locally advanced unresectable or metastatic GC/GEJC (limited to those diagnosed since October 1, 2017) and initiating first-line treatment between January 1, 2018, and March 31, 2023\n* Patients aged ≥ 18 years at the time of diagnosis with locally advanced unresectable or metastatic GC/GEJC; HER2-positive status2, determined by either tissue samples from the first biopsy or liquid biopsy samples (if a patient has both tissue and liquid biopsy samples, tissue samples will be the standard).\n\nExclusion criteria\n\n* Patients with other primary malignant tumors\n* Patients enrolled in clinical trials and receiving active anti-cancer therapy after July.1, 2017 (excluding retrospective studies).\n* Patients with critical missing data in medical records or otherwise deemed for inclusion by the investigator"
},
"inclusion_lines": [
{
"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"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Patients with pathologically diagnosed locally advanced unresectable or metastatic GC/GEJC (limited to those diagnosed since October 1, 2017) and initiating first-line treatment between January 1, 2018, and March 31, 2023",
"criterions": [
{
"exact_snippets": "pathologically diagnosed locally advanced unresectable or metastatic GC/GEJC",
"criterion": "GC/GEJC diagnosis",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": [
"locally advanced unresectable",
"metastatic"
]
}
},
{
"exact_snippets": "diagnosed since October 1, 2017",
"criterion": "diagnosis date",
"requirement": {
"requirement_type": "date",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2017.1,
"unit": "year"
}
]
}
}
},
{
"exact_snippets": "initiating first-line treatment between January 1, 2018, and March 31, 2023",
"criterion": "treatment initiation date",
"requirement": {
"requirement_type": "date",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2018.01,
"unit": "year"
},
{
"operator": "<=",
"value": 2023.03,
"unit": "year"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "pathologically diagnosed locally advanced unresectable or metastatic GC/GEJC",
"criterion": "GC/GEJC diagnosis",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": [
"locally advanced unresectable",
"metastatic"
]
}
},
{
"exact_snippets": "diagnosed since October 1, 2017",
"criterion": "diagnosis date",
"requirement": {
"requirement_type": "date",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2017.1,
"unit": "year"
}
]
}
}
}
]
},
{
"exact_snippets": "initiating first-line treatment between January 1, 2018, and March 31, 2023",
"criterion": "treatment initiation date",
"requirement": {
"requirement_type": "date",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2018.01,
"unit": "year"
},
{
"operator": "<=",
"value": 2023.03,
"unit": "year"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients aged ≥ 18 years at the time of diagnosis with locally advanced unresectable or metastatic GC/GEJC; HER2-positive status2, determined by either tissue samples from the first biopsy or liquid biopsy samples (if a patient has both tissue and liquid biopsy samples, tissue samples will be the standard).",
"criterions": [
{
"exact_snippets": "Patients aged ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "locally advanced unresectable or metastatic GC/GEJC",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced unresectable",
"metastatic"
]
}
},
{
"exact_snippets": "HER2-positive status",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "determined by either tissue samples from the first biopsy or liquid biopsy samples",
"criterion": "biopsy type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"tissue",
"liquid"
]
}
},
{
"exact_snippets": "if a patient has both tissue and liquid biopsy samples, tissue samples will be the standard",
"criterion": "biopsy sample preference",
"requirement": {
"requirement_type": "preference",
"expected_value": "tissue"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients aged ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "locally advanced unresectable or metastatic GC/GEJC",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced unresectable",
"metastatic"
]
}
},
{
"exact_snippets": "HER2-positive status",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "determined by either tissue samples from the first biopsy or liquid biopsy samples",
"criterion": "biopsy type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"tissue",
"liquid"
]
}
},
{
"exact_snippets": "if a patient has both tissue and liquid biopsy samples, tissue samples will be the standard",
"criterion": "biopsy sample preference",
"requirement": {
"requirement_type": "preference",
"expected_value": "tissue"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients with other primary malignant tumors",
"criterions": [
{
"exact_snippets": "Patients with other primary malignant tumors",
"criterion": "primary malignant tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients with other primary malignant tumors",
"criterion": "primary malignant tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients enrolled in clinical trials and receiving active anti-cancer therapy after July.1, 2017 (excluding retrospective studies).",
"criterions": [
{
"exact_snippets": "Patients enrolled in clinical trials",
"criterion": "clinical trial enrollment",
"requirement": {
"requirement_type": "status",
"expected_value": "enrolled"
}
},
{
"exact_snippets": "receiving active anti-cancer therapy",
"criterion": "anti-cancer therapy",
"requirement": {
"requirement_type": "status",
"expected_value": "receiving"
}
},
{
"exact_snippets": "after July.1, 2017",
"criterion": "date of therapy",
"requirement": {
"requirement_type": "start date",
"expected_value": "> July 1, 2017"
}
},
{
"exact_snippets": "excluding retrospective studies",
"criterion": "study type",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "retrospective studies"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients enrolled in clinical trials",
"criterion": "clinical trial enrollment",
"requirement": {
"requirement_type": "status",
"expected_value": "enrolled"
}
},
{
"exact_snippets": "receiving active anti-cancer therapy",
"criterion": "anti-cancer therapy",
"requirement": {
"requirement_type": "status",
"expected_value": "receiving"
}
},
{
"exact_snippets": "after July.1, 2017",
"criterion": "date of therapy",
"requirement": {
"requirement_type": "start date",
"expected_value": "> July 1, 2017"
}
}
]
},
{
"not_criteria": {
"exact_snippets": "excluding retrospective studies",
"criterion": "study type",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "retrospective studies"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients with critical missing data in medical records or otherwise deemed for inclusion by the investigator",
"criterions": [
{
"exact_snippets": "critical missing data in medical records",
"criterion": "medical records",
"requirement": {
"requirement_type": "data completeness",
"expected_value": false
}
},
{
"exact_snippets": "deemed for inclusion by the investigator",
"criterion": "investigator's discretion",
"requirement": {
"requirement_type": "inclusion decision",
"expected_value": "investigator's discretion"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "critical missing data in medical records",
"criterion": "medical records",
"requirement": {
"requirement_type": "data completeness",
"expected_value": false
}
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{
"and_criteria": [
{
"exact_snippets": "deemed for inclusion by the investigator",
"criterion": "investigator's discretion",
"requirement": {
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"expected_value": "investigator's discretion"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "Inclusion criteria",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Exclusion criteria",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}