A Cross-sectional, Hospital-based, Epidemiological Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) and/or Cervical Intraepithelial Neoplasia (CIN) II and/or CIN III in Sri Lanka

GlaxoSmithKline0 个研究点目标入组 40 人开始时间: 2009年10月最近更新: 2012年4月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 40
主要终点: Detection of human papillomavirus-16, human papillomavirus-18 in invasive cervical cancer and cervix intraepithelial neoplasia- moderate or cervix intraepithelial neoplasia- severe by short PCR fragment polymerase chain reaction and line probe assay

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The current study will elucidate the human papillomavirus type distribution in a population of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical cancer in Sri Lanka.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Cross Sectional

入排标准

年龄范围: 21 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•A female > 21 years of age at the time of diagnosis of invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe.
•Histologically confirmed diagnosis of cervix intraepithelial neoplasia - moderate or severe, invasive cervical cancer, glandular lesions and other epithelial tumours.
•Written informed consent obtained from the subject prior to study start.
•Subjects who the investigator believes can and will comply with the requirements of the protocol, should be enrolled in the study.

排除标准

•Previous vaccination against human papillomavirus.
•History of chemotherapy or radiotherapy for cervical cancer.
•Subjects with recurrent episodes of invasive cervical cancer or cervical intraepithelial neoplasia- moderate or severe.

结局指标

主要结局

Detection of human papillomavirus-16, human papillomavirus-18 in invasive cervical cancer and cervix intraepithelial neoplasia- moderate or cervix intraepithelial neoplasia- severe by short PCR fragment polymerase chain reaction and line probe assay

时间窗: Up to 12 months from the date of study initiation

次要结局

Detection of other high risk types in invasive cervical cancer and cervical intraepithelial neoplasia moderate or severe by short PCR fragment polymerase chain reaction and line probe assay(Up to 12 months from the date of study initiation)
Occurrence of human papillomavirus-16, human papillomavirus-18 or other high risk types in relation to covariates(Up to 12 months from the date of study initiation)
Detection of co-infection of human papillomavirus-16 and human papillomavirus-18 in relation to other high risk types(Up to 12 months from the date of study initiation)

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

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