Genotypification and Predisposing Factors in Human Papilloma Virus Infection and Its Association With the Carbohydrate Antigen (CA-125) Tumoral Marker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 主要终点
- Multiple HPV infection
研究概览
简要总结
Objective: Determine the genotypes and risk factors associated with human papilloma virus infection in Mexican women.
Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital "Mónica Pretelini" and the Medical Research Center (CICMED), who were asked to complete a risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).
详细描述
Principles: The aim of this study was to determine the HPV genotypes in squamous intraepithelial lesions (SIL) in a population sample of the State of Mexico.
Patients:
The inclusion criteria were women submitted to a colposcopy study at the Clinic 221 of the Mexican Social Security Institute (IMSS), Maternal-Perinatal Hospital "Monica Pretelini" (HMPMP), State of Mexico Health Institute (ISEM) and the Medical Research Center (CICMED), Autonomous University of State of México (UAEMex). Women with previous conization were not considered into the study and those whose clinical follow up was lost were excluded.
Sociodemographic factors:
Patients were given a questionnaire to measure the following potential risk factors: age, area of residence, education level, sexual partners, participation in anal sex, age at first intercourse, smoking, use of hormonal contraception, use of condoms, number of pregnancies and vaginal deliveries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active women 18 to 40 years of age who come to consult the dysplasia clinic.
- •Who are not pregnant
- •Who have not received pharmacological treatment with antibiotics and / or anti-inflammatory drugs at least one month before the study.
- •Who agreed to participate in the study and signed the informed consent letter.
- •Acceptance to fill the questionnaire with relevant data related to HPV risk infection
排除标准
- •Inadequate samples
- •Questionnaires with incomplete data
- •Women who decided to leave the study
结局指标
主要结局
Multiple HPV infection
时间窗: At the moment of the colposcopy
While women are revised by colposcopy the Gynecologist will refer them to a cervical swab for DNA extraction in case of suspicious of HPV infection.
次要结局
- squamous intraepithelial lesions(Within one week after the cervical sample taken by the technician)
研究者
Hugo Mendieta Zeron
Doctor
Materno-Perinatal Hospital of the State of Mexico