"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
4. Selection of Study Population
100 consecutive patients with gastric cancer who have a pathology specimen at TMH
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.
Time Perspective: Prospective
Incidence of Her2 testing in Gastric cancer
Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
Dr Bhawna Sirohi, MBBS DCH
Consulting Medical Oncologist
India: Data Monitoring Committee