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临床试验/NCT06509555
NCT06509555招募中不适用

Establishment of Serum TK1 Combined With MRI to Predict Pathological Remission of Breast Cancer With Neoadjuvant Chemotherapy

Yunnan Cancer Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Correlation analysis of serum TK1 and pathological remission of breast cancer with neoadjuvant chemotherapy

研究概览

简要总结

The levels and changes of sTK1 among different outcome groups in BCs with different molecular types were compared by stratification to explore whether sTK1 can be used as one of the tumor markers to predict pathological remission of NACT in BC patients.The changes of serum sTK1 level and ADC before surgery were continuously monitored, and combined with other clinicopathological factors, the pathological remission prediction model of NACT in BC patients was constructed and verified.

详细描述

Female patients diagnosed with breast cancer by breast biopsy and receiving neoadjuvant chemotherapy in our hospital from 2020 to 2024 were selected as the study objects, and their puncture pathology data, general clinical characteristics, hematology test data, imaging data and surgical pathology data were collected, and the data were collated for statistical analysis. The influencing factors of pCR after neoadjuvant therapy were determined by univariate and multivariate logistic regression analysis, and the nomogram and ROC curve were drawn. The model was verified internally through bootstrap resampling 1000 times, and the correction curve was drawn to evaluate the prediction ability of the model.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ① The patient was diagnosed with breast cancer by biopsy, and there were complete pathological data. ② Complete the course of neoadjuvant chemotherapy; ③ After the end of neoadjuvant therapy, the operation was performed and the postoperative pathology was obtained; MRI and serum TK1 data were complete (baseline, after 2 cycles of chemotherapy, 4 cycles of chemotherapy, and 6 cycles of chemotherapy).

排除标准

  • ① Distant metastasis at first diagnosis (stage IV); ② With other primary malignant tumors.

结局指标

主要结局

Correlation analysis of serum TK1 and pathological remission of breast cancer with neoadjuvant chemotherapy

时间窗: 2026.02

次要结局

未报告次要终点

研究者

发起方
Yunnan Cancer Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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