Evaluation of the Prevalence and Type of Oral HPV Infection in Patients Who Are Positive to the PAP-test
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess whether there are any factors that may or may not promote the occurrence of oral HPV lesions in PAP-test positive patients,
研究概览
简要总结
The present cross-sectional study aims to assess the prevalence and type distribution of oral HPV infection in PAP-test-positive women aged ≥18 years. The means used in the present study will be the use of anamnestic questionnaires and exfoliative cytology tests at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).
详细描述
The present cross-sectional study aims to evaluate the prevalence and distribution of the type of oral HPV infection in PAP-test positive women.
aged ≥18 years. Sociodemographic and anamnestic data will be collected by questionnaire administration. Data collected will be age, marital status, number of sexual partners, HPV vaccination, oral sex, contraceptive use, systemic diseases, smoking, alcohol consumption, etc.. Next, patients will undergo oral cavity inspection and exfoliative cytology testing at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).
Sample taken sent for cytological analysis to determine the presence of viral DNAand possible typing.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients with positive PAP test;
- •Age ≥ 18 years
排除标准
- •Female patients with negative PAP test
- •Uncooperative patients
- •Patients with mental deficits
- •Age<18 years
结局指标
主要结局
To assess whether there are any factors that may or may not promote the occurrence of oral HPV lesions in PAP-test positive patients,
时间窗: 1 Month
To assess whether there are any factors that may or may not promote the occurrence of oral HPV lesions in PAP-test positive patients, such as sociodemographic characteristics, diabetes, smoking, alcohol, HPV vaccination, etc. The data collected are as follows: * Collection of sociodemographic data by questionnaires (age, gender, civil status, education level, and occupation); * Collection of medical history data by questionnaires (smoking, alcohol consumption, diabetes or/and other systemic diseases, number of sexual partners, age of first intercourse, contraceptive use, type of contraceptive, HPV vaccination, sexual partners with genital/oral HPV infection). the following collected data will then be processed by statistical association surveys and uni and multivariate regression analyses.
Prevalence and type of oral HPV infection in PAP-test positive patients
时间窗: 1 Month
Evaluation of the prevalence and type of oral HPV infection in PAP-test positive patients by objective examination of the oral cavity and performance of exfoliative cytology tests at oral mucosal sites predetermined (lingual belly and dorsum, palate, and buccal mucosa). The data will then be processed through the appropriate statistical examinations.
次要结局
未报告次要终点
研究者
Gaetano Isola
Principal Investigator
University of Catania