Observational Study for Determine the Presence and Genotypes of HVP Infection in Cervical Intraepithelial Neoplasia Grade II-III (CIN II-III), and Stage I Cervical Epidermoid Carcinoma and Cervical Adenocarcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 329
- 试验地点
- 2
- 主要终点
- HPV Type 18
研究概览
简要总结
- Hypothesis:
If high risk genotypes of human papillomavirus (HPV) is the cause of cervical cancer worldwide, the genotypes associated with cervical cancer in Venezuela would be the same types found in other countries. 2. Objectives:
Primary objective:
The objective of this investigation is to determine the presence and genotypes of HVP infection in cervical intraepithelial neoplasia grade 2/3 (CIN 2/3), and Stage I cervical epidermoid carcinoma and cervical adenocarcinoma.
Specific objectives:
To establish the presence of HPV in cervical cancer patients in Venezuela by geographic distribution.
To establish which HPV types are linked with cervical cancer in Venezuela by geographic distribution.
详细描述
In Venezuela, cervical cancer is the second leading cause of cancer mortality in women. In developed countries, although it is not the first cause of cancer mortality, occupies a remarkable place in the neoplastic pathology (Cannistra, 1996; Dey, 1998).
Human Papilloma Virus (HPV) is involved in the development of cervical cancer, specially oncogenic types 16 and 18 (Koskela, 2000; Markowska, 1999).
To date, it is still unknown which HPV types are more frequent in Venezuela. Several studies made in this country concluded that HPV 16 is the predominant type in cervical pathology (Graterol 2006, Correnti 1997, Muñoz 2003), but there has not been performed a HVP genotyping to detect all the types involved in patients with cervical cancer. Neither has been establish which HPV types are more frequently involved in genital warts in Venezuela.
The goal of this investigation is perform a genotypification of HPV in cervical cancer and cervical intraepithelial neoplasia 2 and 3 in Venezuela to determine which types are more frequently related to this disease in our country.
- STUDY DESIGN:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •paraffin blocks of 329 patients with histologic diagnosis of CIN 2, CIN 3 or Stage I cervical cancer. -
排除标准
- 未提供
结局指标
主要结局
HPV Type 18
时间窗: 6 months
Number of biopsies positive to HPV 18.
HPV Identification
时间窗: 6 months
HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer
HPV Type 31
时间窗: 6 months
Number of biopsies positive to HPV 31.
HPV Type 33
时间窗: 6 months
Number of biopsies positive to HPV 33.
HPV Type 58
时间窗: 6 months
Number of biopsies positive to HPV 58.
HPV Type 51
时间窗: 6 months
Number of biopsies positive to HPV 51.
HPV Type 16
时间窗: 6 months
Number of biopsies positive to HPV 16.
HPV Type 45
时间窗: 6 months
Number of biopsies positive to HPV 45.
次要结局
未报告次要终点
研究者
Dr. Jorge Sanchez Lander
Dr. Jorge Sanchez-Lander
Instituto Oncologico Luis Razetti