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临床试验/NCT03895905
NCT03895905已完成不适用

Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity in Normal Women With Cytology

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
409
试验地点
1
主要终点
Genotype of HR-HPV 16/18

研究概览

简要总结

The only malignancy screening test among gynecological cancers is cervical cancer.

Cytology examination and Hpv typing with smear are used as screening tests. Hpv positivity is detected in more than 90% of cervical cancers. However, only the Hpv 16-18 type positive patients undergo colposcopy in the routine screening program.

Patients with Smear negative, Type 16-18 high-risk Hpv positivity are evaluated by quota after 1 year.

the authors performed colposcopy with this study; authors aimed to compare the results of patients with type 16-18 Hpv positivity and type 16-18 high-risk Hpv positivity and to find out whether there was any difference between them.

In this way, other high-risk Hpv types other than type 16-18 (31,33,35,45,51, etc.) may be exposed to premalign cervical lesions and possible cancer in a number of earlier and earlier periods by performing colposcopic examination instead of expecting to perform quota after 1 year. we aimed to remove.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • 20-65 years old
  • patients with normal smear

排除标准

  • Patients with invasive cervical cancer,
  • HIV-positive patients,
  • ASCUS and more risky premalignant lesions in cytology,
  • Over the age of 65 and
  • Patients under 20 years of age,
  • patients with another known gynecological malignancy

结局指标

主要结局

Genotype of HR-HPV 16/18

时间窗: 1 MONTH

Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV 16/18

Genotype of HR-HPV non 16/18

时间窗: 1 MONTH

Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV non 16/18

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

Pınar Kadirogulları

principal investigator, M.D, Department of Obstetrics and Gynecology

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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