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临床试验/NCT06394050
NCT06394050尚未招募不适用

Utilizing Label-free Raman Spectroscopy for Discrimination Between Breast Cancer Tumor and Adjacent Tissues in Patients After Neoadjuvant Treatment

RenJi Hospital0 个研究点目标入组 150 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
Diagnostic performance

研究概览

简要总结

After neoadjuvant therapy, the primary lesion in breast cancer patients may experience tumor regression, which increases the difficulty of distinguishing between breast cancer and adjacent tissues. Raman spectroscopy is a form of scattering spectroscopy, which offers rapid and sensitive analysis, delivering detailed biochemical information and molecular signatures of internal molecular components within the sample. This study aims to discern between cancer and adjacent tissues after neoadjuvant therapy in breast cancer patients using label-free Raman spectroscopy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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) aged ≥ 18 years; (2) histologically confirmed invasive breast cancer (clinical tumor stage T1 to T4, nodal stage N1-3, and metastasis stage M0); (3) previous treatment with neoadjuvant chemotherapy with or without target therapy (such as trastuzumab, pertuzumab), or endocrine therapy; (4) enough frozen samples of breast cancer tumor and adjacent tissue.

排除标准

  • (1) undergoing sentinel lymph node biopsy with indocyanine green dye or methylene blue injection after neoadjuvant therapy; (2) Breast cancer during pregnancy and lactation, inflammatory breast cancer.

结局指标

主要结局

Diagnostic performance

时间窗: Baseline

Area under curve, accuracy, sensitivity, specificity,

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinsong Lu

Chief of Department of Breast Surgery

RenJi Hospital

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