{
"info": {
"nct_id": "NCT06649565",
"official_title": "Prospective Validation and Application of an Artificial Intelligence-based Model for Evaluating the Efficacy of Breast Cancer Patients After Neoadjuvant Therapy",
"inclusion_criteria": "* Patients who were treated in the above research centers between January 1, 2024 and October 31, 2025;\n* ≥18 years old, female, ECOG score ≤2;\n* Pathological biopsy confirmed invasive breast cancer;\n* AJCC (8th edition) stage I-III;\n* MRI imaging data before and after neoadjuvant therapy;\n* Planned mastectomy or breast-conserving surgery after neoadjuvant therapy, and postoperative pathological information obtained.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Bilateral breast cancer, multiple lesions, or occult breast cancer;\n* Poor MRI data quality;\n* Patients who had received other anti-tumor treatments before enrollment;\n* Patients with other malignant tumors",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients who were treated in the above research centers between January 1, 2024 and October 31, 2025;",
"criterions": [
{
"exact_snippets": "treated in the above research centers",
"criterion": "treatment location",
"requirement": {
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"expected_value": "above research centers"
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},
{
"exact_snippets": "between January 1, 2024 and October 31, 2025",
"criterion": "treatment date",
"requirement": {
"requirement_type": "date range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2024,
"unit": "year"
},
{
"operator": "<=",
"value": 2025,
"unit": "year"
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]
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}
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},
"logical_structure": {
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{
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"line": "* ≥18 years old, female, ECOG score ≤2;",
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{
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"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
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},
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"criterion": "gender",
"requirement": {
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},
{
"exact_snippets": "ECOG score ≤2",
"criterion": "ECOG score",
"requirement": {
"requirement_type": "maximum score",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
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"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
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}
},
{
"identified_line": {
"line": "* Pathological biopsy confirmed invasive breast cancer;",
"criterions": [
{
"exact_snippets": "Pathological biopsy confirmed invasive breast cancer",
"criterion": "invasive breast cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "pathological biopsy"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Pathological biopsy confirmed invasive breast cancer",
"criterion": "invasive breast cancer",
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"expected_value": "pathological biopsy"
}
}
]
}
},
{
"identified_line": {
"line": "* AJCC (8th edition) stage I-III;",
"criterions": [
{
"exact_snippets": "AJCC (8th edition) stage I-III",
"criterion": "AJCC stage",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
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},
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"criterion": "AJCC stage",
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"expected_value": {
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"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
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}
}
}
]
}
},
{
"identified_line": {
"line": "* MRI imaging data before and after neoadjuvant therapy;",
"criterions": [
{
"exact_snippets": "MRI imaging data before and after neoadjuvant therapy",
"criterion": "MRI imaging data",
"requirement": {
"requirement_type": "timing",
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"before neoadjuvant therapy",
"after neoadjuvant therapy"
]
}
}
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},
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"exact_snippets": "MRI imaging data before and after neoadjuvant therapy",
"criterion": "MRI imaging data",
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"after neoadjuvant therapy"
]
}
}
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}
},
{
"identified_line": {
"line": "* Planned mastectomy or breast-conserving surgery after neoadjuvant therapy, and postoperative pathological information obtained.",
"criterions": [
{
"exact_snippets": "Planned mastectomy or breast-conserving surgery",
"criterion": "surgery type",
"requirement": {
"requirement_type": "planned",
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"breast-conserving surgery"
]
}
},
{
"exact_snippets": "after neoadjuvant therapy",
"criterion": "neoadjuvant therapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "before surgery"
}
},
{
"exact_snippets": "postoperative pathological information obtained",
"criterion": "postoperative pathological information",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
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"breast-conserving surgery"
]
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"criterion": "neoadjuvant therapy",
"requirement": {
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"expected_value": "before surgery"
}
}
]
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{
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"criterion": "postoperative pathological information",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
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},
{
"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": {
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
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"unit": "Years"
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],
"exclusion_lines": [
{
"identified_line": {
"line": "* Bilateral breast cancer, multiple lesions, or occult breast cancer;",
"criterions": [
{
"exact_snippets": "Bilateral breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "laterality",
"expected_value": "bilateral"
}
},
{
"exact_snippets": "multiple lesions",
"criterion": "lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": "multiple"
}
},
{
"exact_snippets": "occult breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "visibility",
"expected_value": "occult"
}
}
]
},
"logical_structure": {
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"criterion": "breast cancer",
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"expected_value": "bilateral"
}
}
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{
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]
}
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},
{
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"line": "* Poor MRI data quality;",
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"exact_snippets": "Poor MRI data quality",
"criterion": "MRI data quality",
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}
},
{
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{
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"criterion": "prior anti-tumor treatments",
"requirement": {
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"expected_value": true
}
}
]
},
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}
},
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"criterion": "malignant tumors",
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}
}
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}