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临床试验/NCT06433804
NCT06433804已完成不适用

Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers

Vardhman Mahavir Medical College And Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Age (in years)

研究概览

简要总结

This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre.

This study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading.

Routine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023

排除标准

  • Benign breast tumors

结局指标

主要结局

Age (in years)

时间窗: JANUARY 2022- DECEMBER 2023

It will be measured for HER2 low breast cancer patients

Tumor grade (categorised from G1-G3)

时间窗: JANUARY 2022- DECEMBER 2023

This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients.

Tumor stage (categorised from T1-T4)

时间窗: JANUARY 2022- DECEMBER 2023

This denotes status of stage of tumor- T1, T2, T3, T4. It will be measured for HER2 low breast cancer patients

N stage (categorised from N0-N3)

时间窗: JANUARY 2022- DECEMBER 2023

This denotes status of nodal involevement- N0, N1, N2 or N3. It will be measured for HER2 low breast cancer patients

Androgen receptor expression (Denoted as present or absent)

时间窗: JANUARY 2022- DECEMBER 2023

This denoted the immunohistochemical expression of androgen receptor which would be evaluted in all cases of HER2 low breast cancer

Surrogate molecular classification (Categorised as luminal/ triple negative)

时间窗: JANUARY 2022- DECEMBER 2023

This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.

次要结局

未报告次要终点

研究者

发起方
Vardhman Mahavir Medical College And Safdarjung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

SANA AHUJA

ASSISTANT PROFESSOR

Vardhman Mahavir Medical College And Safdarjung Hospital

研究点 (1)

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