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临床试验/NCT07758127
NCT07758127尚未招募不适用

Updates and Insights on Human Epidermal Growth Factor Receptor 2 (HER2) in Breast Cancer in Sohag Governorate

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026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
100
试验地点
1
主要终点
HER2 status in breast cancer

研究概览

简要总结

  • To evaluate HER2 expression in breast carcinoma with emphasizing HER2-ultralow, and HER2-low, HER2 equivocal tumors.
  • To correlate the results of HER2 with clinico-pathological prognostic parameters; examples tumor grade, Ki-67 proliferation index, nodal status, tumor size, lympho-vascular invasion, and perineural invasion, tumor infiltrating lymphocytes
  • To access interobserval agreement in HER2 score interpretation

详细描述

HER2 status is no longer simply classified as a positive or negative. It is now evaluated on a score from 0 to 3+, where score 3+ indicates HER2-positive disease because it shows strong, complete circumferential membranous staining. In the HER2-negative spectrum, score 1+ and score 2+ without gene amplification are classified as HER2-low, while score 0 involves both HER2-null cases with no membrane staining and HER2-ultralow cases with faint or weak incomplete membranous staining in ≤10%, of tumor cells. In addition, ISH can be used to determine HER2 gene amplification status. The emergence of HER2-low and also HER2-ultralow concepts has challenged the traditional binary framework and increased the need for collective reporting. As a result, careful interpretation of delicate staining patterns, reproducible scoring and appropriate use of complementary testing methods are now central to accurate HER2 classification in both primary and metastatic breast cancer.

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
26 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Breast cancer cases diagnosed during 2025 and
  • •Cases with available HER2 immunohistochemical results.
  • •Cases with sufficient tissue material for evaluation.
  • •Cases with complete clinical and follow-up data.
  • •Cases that were accessible for pathologic review

排除标准

  • •Cases with insufficient, destroyed, necrotic, or unavailable tissue blocks.
  • •Cases with incomplete clinical information.
  • •Cases lacking adequate immunohistochemical assessment.
  • •Cases outside the study period

研究组 & 干预措施

Breast cancer female patients

Female patients with histopathologically confirmed breast cancer diagnosed at Sohag Oncology center during 2025-2026. Archived formalin-fixed paraffin-embedded tissue samples and pathology records will be retrospectively reviewed to evaluate HER2 status by immunohistochemistry (IHC)

结局指标

主要结局

HER2 status in breast cancer

时间窗: 2025/2026

To evaluate the HER2 status among breast cancer patients diagnosed at Sohag Oncology center using immunohistochemistry (IHC) and, when indicated, in situ hybridization (ISH), and to describe the distribution of HER2 expression.

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

Rana Amgad Anwar

Pathology resident at Sohag Oncology Center

Sohag University

研究点 (1)

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