跳至主要内容
临床试验/CTRI/2025/12/099951
CTRI/2025/12/099951尚未招募不适用

Role Of p16 and Ki-67 Immunocytochemistry along with HPV testing in Cervical Epithelial Abnormalities

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
The main goal is to find out how accurately p16 Ki-67 and HPV testing can help detect and confirm early changes or abnormal changes of cancer of cervix when compared to standard histopathological examination

研究概览

简要总结

Cervical cancer is a common cancer among women in India, and early detection through screening can greatly reduce deaths. However, routine screening tests like Pap smear and HPV testing have limitations and may lead to unnecessary biopsies. This study aims to evaluate the role of additional biomarkers, p16 and Ki-67, using immunocytochemistry along with HPV testing, in detecting cervical epithelial abnormalities. Since p16 indicates HPV-related cell changes and Ki-67 shows cell proliferation, their combined use may improve diagnostic accuracy. The results will be correlated with histopathology, which is considered the gold standard.

Purpose:The purpose of this study is to find out whether p16 and Ki-67 tests, when used along with HPV testing, can improve the diagnosis of cervical epithelial abnormalities. This will help in better identification of serious lesions, reduce unnecessary biopsies, and improve patient management.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • Newly diagnosed cases of cervical epithelial abnormalities.

排除标准

  • Cases of cervical infections and inflammatory lesions.Recurrent cases of cervical epithelial abnormalities.Age less than 21 years.

结局指标

主要结局

The main goal is to find out how accurately p16 Ki-67 and HPV testing can help detect and confirm early changes or abnormal changes of cancer of cervix when compared to standard histopathological examination

时间窗: Baseline

次要结局

  • p16 and Ki-67 expression and HPV testing in different categories of cervical epithelial abnormalities as per The Bethseda System.(Baseline)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Prachi Prajapati

Maulana Azad Medical College

研究点 (1)

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