Using GATA-3 and KRT 5/6 IHC markers for molecular phenotyping of bladder carcinoma: A Cross sectional study.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- ROHILKHAND MEDICAL COLLEGE
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- To determine the immunohistochemical expression of GATA-3 and KRT 5/6 in all histologically confirmed cases of urinary bladder carcinoma and categorise them in basal and luminal phenotypes accordingly.
Overview
Brief Summary
The study will be conducted in the Department of Pathology Rohilkhand Medical College and Hospital, Bareilly after obtaining approval from the Institutional Ethics Committee and will include all urinary bladder biopsy specimens received in the department in a one-year duration.
The received formalin-fixed biopsy specimens will be subjected to gross and microscopic examination as per standard protocol.
Haematoxylin and Eosin stains will be used to stain the previously cut paraffin-embedded tissues (4-5 microns).
Sections will be deparaffinized for immunohistochemistry, and Heat-Induced Epitome Retrieval (HIER) will be carried out using an EDTA buffer.
Tissue slices will be incubated with ready-to-use antibodies against IHC markers at a dilution of 1:100.
A 3,3’-diaminobenzene (DAB) detection kit, a hydrogen peroxide substrate, and a DAB chromogen will be utilized for the detection process. A DAB chromogen will be used to evaluate the markers’ antibody staining.
On IHC stained slides, observations will be taken and recorded.
In this study, the immunohistochemical markers GATA 3 and KRT 5/6 will be used.
IMMUNOHISTOCHEMICAL ANALYSIS: The prepared slides will be examined for positive or negative immunostaining using an optical microscope at x400 magnification.
STATISTICAL ANALYSIS: Data will be entered in SPSS (Statistical Package for social sciences); licensed version 23.0. Descriptive analysis will be done by calculating proportions, means and standard deviation. Appropriate statistical tests will be applied depending on the type and distribution of data. p <0.05 will be considered significant
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All histopathologically confirmed cases of bladder carcinoma that will be received in our department.
Exclusion Criteria
- •The biopsy reported as unsatisfactory and patients who are not willing to give consent.
- •Tissue is insufficient for reporting.
Outcomes
Primary Outcomes
To determine the immunohistochemical expression of GATA-3 and KRT 5/6 in all histologically confirmed cases of urinary bladder carcinoma and categorise them in basal and luminal phenotypes accordingly.
Time Frame: 7 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehnaz Munawar
Rohilkhand medical college and hospital