跳至主要内容
临床试验/CTRI/2024/04/065698
CTRI/2024/04/065698尚未招募不适用

Comparison of Primary Human Papilloma Virus testing, Liquid based cytology and Co-testing for cervical cancer screening

Sneha Arora1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年4月22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
500
试验地点
1
主要终点
Detection of pre-malignant and malignant lesions of cervix

研究概览

简要总结

A prospective study will be performed on married women, above the age of 30 years presenting to OPD of Department of obstetrics and gynaecology ABVIMS and Dr RML NEW DELHI hospital. Those who are found to meet the inclusion and exclusion criteria will be explained the study details in their own language and a written informed consent to participate in the study will be taken. History and thorough examination shall be as per attached proforma. A per speculum examination using Cusco’s bivalve metallic speculum will be performed and samples for both HPV DNA and LBC will be collected using HPV kit and cytology brush respectively and will be sent for examination. Those who come out to be screen positive will be subjected to cervical biopsy and managed as per hospital protocols.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Women more than 30 years of age.

排除标准

  • Pregnant women
  • Women with history of cervical surgery
  • Women diagnosed with cervical cancer
  • HPV vaccinated women
  • Post hysterectomised women.

结局指标

主要结局

Detection of pre-malignant and malignant lesions of cervix

时间窗: More than 30 years of age

次要结局

  • Prevalence of HPV infection in Indian women(More than 30 years of age)

研究者

发起方
Sneha Arora
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sneha Arora

ABVIMS, Dr. RML hospital , Delhi

研究点 (1)

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