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临床试验/NCT01814345
NCT01814345终止不适用

"An Observational Study to Determine the Incidence of of Her 2 Positivity in 100 Consecutive Gastric Cancers"

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
1
主要终点
Incidence of Her2 testing in Gastric cancer

研究概览

简要总结

Gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. The investigators have very few options for patients with advanced disease.

The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months; HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas.

Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100 patients with IHC and FISH in 2+ and 3+ patients.

详细描述

  1. Study Objective/ Aims Aim: - Rate of Her 2 positivity in 100 consecutive gastric cancer patients Primary Objective

Test for Her 2 in 100 consecutive gastric cancer patients Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done. 2. Study Design& Methodology

Patients will have the Her2 tested in 100 consecutive gastric cancer samples by immunohistochemistry and patients with 2+ and 3+ result will also have FISH done. This will not affect patient management 3. Overview of Data collection Dr.Bhawna Sirohi the principal investigators will maintain and supervise data collection and maintaining records. The patient will be de-identified. 4. Selection of Study Population

Inclusion Criteria:

100 consecutive patients with gastric cancer who have a pathology specimen at TMH

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 100 consecutive patients with gastric cancer who have a pathology specimen at TMH

排除标准

  • If histopathology blocks were not available

结局指标

主要结局

Incidence of Her2 testing in Gastric cancer

时间窗: 6 month

Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.

次要结局

未报告次要终点

研究者

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

Dr Bhawna Sirohi

Consulting Medical Oncologist

Tata Memorial Hospital

研究点 (1)

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