Her 2 Testing in Indian Patients With Gastric Cancer

April 25, 2017 updated by: Dr Bhawna Sirohi, Tata Memorial Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

  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

Exclusion Criteria:

If histopathology blocks were not available

5) Sample size 100 to be enrolled. Patient consent waiver applied for as this does not affect patient care 6) Statistical Analysis It is an Observational study so Results will be given as %age of total population.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 consecutive Gastric Cancer

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • If histopathology blocks were not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Her2 testing in Gastric cancer
Time Frame: 6 month
Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Investigators

  • Principal Investigator: Dr Bhawna Sirohi, MBBS DCH, Consulting Medical Oncologist
  • Principal Investigator: Shailesh Shrikhande, MS, Professor of Surgical GI and HPB surgery
  • Principal Investigator: Mukta Ramadwar, MD, Consultant Pathologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 19, 2013

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1077
  • Her 2 in gastric cancer (Other Grant/Funding Number: Roche pharma limited)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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