跳至主要内容
临床试验/CTRI/2010/091/006076
CTRI/2010/091/006076未知不适用

Early detection of cervical neoplasia by visual screening and hybrid capture testing by self and physician collection methodology - A community based study in rural area

Qiagen India Pvt.Ltd1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 待定

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Detection of CIN via HPV test

研究概览

简要总结

Naked eye visual inspection of the cervix after application of acetic acid (VIA) and HPV testing are alternative methods for cervical cancer screening in low resource settings for reducing the burden of the disease. The high sensitivity and low specificity of VIA results in high referral rates. HPV testing has been shown to be a better screening test than Pap smear and is now being recommended as the method of primary screening for cervical cancer. However, it still suffers from some of the drawbacks of Pap smear. The requirement for a health care provider to collect the samples and many logistic requirements at the periphery, such as examination facilities, sterile speculums, light source, etc., still remain. Self-sampling has shown to have 94% concordance with cervical sampling in our pilot study and was found to have good acceptability among Indian women. The aim of this study is to assess the feasibility and reliability of this method in the community setting, as a model for cervical cancer screening at the primary health centres and sub-centres.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 59.00 Year(s)(—)
性别
Female

入选标准

  • Age > 30 years of age Ability to give informed consent Sexually active No debilitating disease (physically able to undergo study procedures).

排除标准

  • Women who have undergone excision biopsy, cryotherapy and conisation and hysterectomy,Acute cervicitis or vaginitis,PregnancySevere debilitating disease.

结局指标

主要结局

Detection of CIN via HPV test

时间窗: 1 year

次要结局

  • Comparison of self sampling with physician.comparison of VIA-VILI with HC2.(1 Year)

研究者

发起方
Qiagen India Pvt.Ltd

研究点 (1)

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