Immunohistochemical expression of Bcl-2 and Ki-67 in non-neoplastic and neoplastic endometrial lesions- A cross sectional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To classify non neoplastic and neoplastic endometrial lesions on the basis of histomorphology.
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 taking approval from Institutional Ethics
Committee, and consent from the patient and will include all endometrial biopsies and
hysterectomy specimens in the department during the study period.
The received specimens will be subjected to gross and microscopic examination as per
standard protocol.
Paraffin embedded tissues (4-5 microns) will be cut and stained by Haematoxylin and
Eosin stain.
Immunohistochemistry will be carried out using Bcl-2 and Ki-67 as primary antibodies
and High Reactive Polymer as a secondary kit.
Microwave antigen retrieval will be carried out in pH 9 TrisEDTA buffer. Using DAB
as the chromogen, staining.
Observations will be made on Immunohistochemistry stained slides and documented.
Prepared slides will be viewed under an optical microscope x400 magnification, for
positive or negative immunostaining.
Biopsies which shows positive for Bcl-2 and Ki-67 expressions will be included.
Calculations will be made regarding staining percentage and intensity.
The positive number of cells for Bcl-2 expressions will count in 100 epithelial cells and
repeated in 10 HPFs. [7]
Positive epithelial cells will be graded on the basis of intensity. [7]
910
o Grade 0 – Absent
o Grade 1 –Mild
o Grade 2 – Moderate
o Grade 3 – Strong
o Grade 4 – Very strong
Positive control: Placental tissue will be used as a positive control for Bcl-2 whose
staining is always grade 4.[7]
The positive number of cells for Ki-67 expressions will count in 100 epithelial cells and
repeated in 10 HPFs and then positive cells for Ki-67 expressions will be calculated
using the percentage of 1000. these cells will be graded on the basis of their positivity
as follows.[7]
o <5% - Grade 0
o 6-25% - Grade 1
o 26-50% - Grade 2
o 51- 75% - Grade 3
o 76-100% - Grade 4
Positive control: Tonsil will be taken as a control for Ki-67 expression
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •All histopathologically confirmed cases of non neoplastic and neoplastic endometrial lesions.
排除标准
- •Patients who are on hormonal therapy Biopsies diagnosed as the product of conception Biopsies that are unsatisfactory.
结局指标
主要结局
To classify non neoplastic and neoplastic endometrial lesions on the basis of histomorphology.
时间窗: Monthly
To evaluate Bcl-2 and Ki-67 expression in non-neoplastic and neoplastic endometrial lesions.
时间窗: Monthly
To correlate Bcl-2 with Ki-67 expression in these lesions
时间窗: Monthly
次要结局
- To classify non neoplastic & neoplastic endometrial lesions on the basis of histomorphology.
研究者
Pragya chitravanshi
Rohilkhand Medical College and Hospital