Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
研究概览
简要总结
The summary of this study is to know which HPV types are present in genital warts in Argentinean population.
详细描述
This is a prospective study. Patients will be evaluated for the presence of external anogenital warts in our clinic. Biopsy will be performed if patients have genital lesions consistent with genital warts of the external genitalia or perianal area. All patients will be provided with an informed consent for the excision biopsy procedure, before performing the biopsy of the lesion. Biopsy specimens will be held in a formol 10% solution and will be sent to the pathologist. A portion of each sample will be processed for histological analysis, which will be performed by one pathologist. The remainder of each specimen will be saved to extract DNA for PCR analysis. All biopsies will be analyzed by the same pathologist who will confirm the histology of the lesion. A part of the specimen will be kept frozen and if the biopsy confirm genital warts by histology; then the specimen will be analyzed by PCR for the presence of DNA HPV 6 and 11. The PCR analysis will be done by microarrays. Detection is performed in a subtype of array platform system which detects the different types of virus. The reports will be as undetectable / detectable and type.
The study will be conducted in the Institute of Gynecology and Fertility (Institute affiliated with the School of Medicine - University of Buenos Aires).
Chronogram of activities: all activities will be done in a maximum of 60 days
- st visit: detect external genital warts and firm informed consent and take the biopsy
- nd visit: inform the result
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women between 15 and 45 years old, with External Genital Warts
排除标准
- •women taking corticoid therapy, having an immunosuppressed disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known
结局指标
主要结局
Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
时间窗: 4 months
150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type
次要结局
未报告次要终点
研究者
Laura Alicia Fleider
Physician
University of Buenos Aires