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临床试验/NCT03663153
NCT03663153尚未招募不适用

SEMA4C as a Relapse Biomarker in Breast Cancer

Tongji Hospital0 个研究点目标入组 4,200 人开始时间: 2022年9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
4,200
主要终点
diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of SEMA4C in predicting recurrence of breast cancer

研究概览

简要总结

Breast cancer remains the most common cancer in women worldwide. Semaphorin4C (SEMA4C) has previously been identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs). The objective of this study is to investigate SEMA4C's potential role as an early relapse biomarker in breast cancer.

详细描述

Breast cancer remains the most common cancer in women worldwide, with approximately 1.68 million new cases, and 0.52 million deaths, annually. Meanwhile the incidence of breast cancer continues to increase. Although regular clinical examination, mammography, ultrasonography, and magnetic resonance imaging can detect some recurrence patients, the lack of robust biomarkers for monitoring of anti-tumor therapies and detection of recurrence reduce the treatment effectiveness of current strategies for breast cancer.

Semaphorin4C (SEMA4C) has been previously identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs) using in situ laser capture microdissection of lymphatic vessels, followed by cDNA microarray analysis. Moreover, membrane-bound SEMA4C is cleaved by matrix metalloproteinase (MMPs) to release a soluble form of this protein. The study is undertaken to explore SEMA4C's potential role as an early relapse biomarker in breast cancer.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Have histologically confirmed new diagnosis of breast cancer according to biopsy or surgery

排除标准

  • Patients who are not mentally capable of giving written informed consent
  • Serum samples doesn't qualified
  • Patients who refuse follow-up on their conditions
  • Patients with prior cancer history
  • Patients with a diagnosis of other severe acute or chronic medical may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study

结局指标

主要结局

diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of SEMA4C in predicting recurrence of breast cancer

时间窗: 5 years

Analyze the sensitivity, specificity, positive predictive value, negative predictive value, accuracy of SEMA4C in predicting recurrence of breast cancer

次要结局

  • Disease Free Survival(5 years)

研究者

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

Qinglei Gao

Clinical Professor

Tongji Hospital

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