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临床试验/NCT04369339
NCT04369339已完成不适用

Immediate Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology

Bezmialem Vakif University0 个研究点目标入组 185 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
185
主要终点
Dysplasia

研究概览

简要总结

Abnormal cervical cytology was the most common reason for women being referred to the colposcopy unit. We prospectively included the women with negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive High RiskHPV test other than HPV 16 or HPV 18. Comparing the immediate colposcopy findings among women with High Risk HPV other than HVPV16/18 and negative cytology and determine positive predictive values for CIN2+ of other high risk HPV genotypes

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

outcomes assessor blind to clinical data and cytology results

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive HrHPV test other than HPV 16 or HPV 18

排除标准

  • •Previous diagnosis for cervical cancer Previous diagnosis for vaginal cancer Previous diagnosis for cervical dysplasia Previous diagnosis for ASCUS previous history of cervical conisation or hysterectomy previous history ofhysterectomy

研究组 & 干预措施

HPV16/18

Active Comparator

Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology

干预措施: Colposcopy (Other)

Other High Risk HPV Positivity

Experimental

Colposcopy performed to women with High risk HPV positive ,negative for intraepithelial lesions or malignancy cytology

干预措施: Colposcopy (Other)

结局指标

主要结局

Dysplasia

时间窗: 1 month

Pathologic diagnosis of cervical dysplasia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serdar Aydın

Assoc. Prof.

Bezmialem Vakif University

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