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临床试验/CTRI/2024/02/063238
CTRI/2024/02/063238尚未招募不适用

Using GATA-3 and KRT 5/6 IHC markers for molecular phenotyping of bladder carcinoma: A Cross sectional study.

ROHILKHAND MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2024年3月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
61
试验地点
1
主要终点
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.

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All histopathologically confirmed cases of bladder carcinoma that will be received in our department.

排除标准

  • The biopsy reported as unsatisfactory and patients who are not willing to give consent.
  • Tissue is insufficient for reporting.

结局指标

主要结局

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.

时间窗: 7 days

次要结局

未报告次要终点

研究者

发起方
ROHILKHAND MEDICAL COLLEGE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Mehnaz Munawar

Rohilkhand medical college and hospital

研究点 (1)

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