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临床试验/NCT02198365
NCT02198365已完成不适用

Comparison of Human Papillomavirus Integrated DNA and Messenger RNA for Detection and Prediction in Progression of Cervical Neoplasia

Cathay General Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
level of mRNA expression

研究概览

简要总结

The investigators hypothesis is HPV integration could result in expression of oncogene transcripts, and not only constitutive expression but also the level of expression will be decisive for transformation and the maintenance of the malignant phenotype. Moreover, the expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).

详细描述

In the investigators proposal, the investigators will examine at least 250 baseline liquid-based cytology specimens from women with normal cytology, low-grade squamous intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs), microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6, and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral DNA tested by real-time PCR and FISH, along with level of expression in mRNA.

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • cervical neoplasia
  • HPV infection patient

排除标准

  • no HPV infection
  • no intra-epithelial neoplasia lesion

结局指标

主要结局

level of mRNA expression

时间窗: 12 month

次要结局

  • The integrated HPV DNA(12 months)

研究者

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

Chih-Ming Ho

Attending physician

Cathay General Hospital

研究点 (1)

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