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


N/A
18 Years
90 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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.


Inclusion Criteria:



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

Exclusion Criteria:

- If histopathology blocks were not available

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Incidence of Her2 testing in Gastric cancer

Outcome Description:

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

Outcome Time Frame:

6 month

Safety Issue:

No

Principal Investigator

Dr Bhawna Sirohi, MBBS DCH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Consulting Medical Oncologist

Authority:

India: Data Monitoring Committee

Study ID:

1077

NCT ID:

NCT01814345

Start Date:

February 2013

Completion Date:

August 2013

Related Keywords:

  • Gastric Cancer
  • Her2 testing (Human Epidermal Growth Factor Receptor 2)
  • Stomach Neoplasms

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