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临床试验/CTRI/2018/01/011413
CTRI/2018/01/011413已完成不适用

A Study of the Effectiveness of Cervical Cytology versus Visual Inspection after Application of Acetic Acid in the Diagnosis of Precancerous Lesions of Cervix.

Tata Motors Hospital Department of Obstetrics and Gynecology1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2015年6月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
1
主要终点
Sensitivity, Specificity, Positive predictive value and Negative predictive value of Cervical Cytology and Visual Inspection after Application of Acetic Acid and their comparison

研究概览

简要总结

This study is a cross sectional observational comparative single center study comparing visual inspection after application of acetic acid and cervical cytology by Pap smear using histopathology as gold standard ,over 2 years on 146 women aged 20 to 70 years with or without cervical symptoms willing for screening for cervical precancerous lesions. The primary outcome is the sensitivity, specificity, positive predictive value and negative predictive value of cervical cytology and visual inspection after application of acetic acid.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Women with or without cervical symptoms like -Abnormal Discharge per vaginum, post coital bleeding, postmenopausal bleeding, inter-menstrual bleeding, irrespective of the appearance of her cervix, willing to undergo cervical cytology test, visual inspection after application of acetic acid and colposcopy directed biopsy for screening for cervical precancerous lesions.

排除标准

  • Pregnant women or suspicion of pregnancy, women menstruating at the time of examination and women previously diagnosed or treated for precancerous or cancerous cervical lesions.

结局指标

主要结局

Sensitivity, Specificity, Positive predictive value and Negative predictive value of Cervical Cytology and Visual Inspection after Application of Acetic Acid and their comparison

时间窗: Two years

次要结局

  • Cervical Cytology and Visual Inspection after Application of Acetic Acid taken together compared to one of these diagnostic modalities alone(Two years)

研究者

发起方
Tata Motors Hospital Department of Obstetrics and Gynecology
申办方类型
Private hospital/clinic

研究点 (1)

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