Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Prevalence (number/percentage) of HPV infection in oral and anal samples
研究概览
简要总结
The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.
详细描述
Male IBD patients attending the IBD Clinic of Hospital de la Santa Creu i Sant Pau will be screened for eligibility. Informed consent will be obtained from all eligible patients. An anal and oral swab will be performed on all patients to look for HPV infection (HPV DNA test) and cytologic alterations. Patients will be inspected to rule out the presence of HPV-related lesions. Moreover, a self-administered questionnaire will be completed by all enrolled patients. Information regarding IBD characteristics and treatment will be obtained.
According to local practice, patients with anal or oral squamous intraepithelial lesions (ASIL) will be referred to a colorectal surgeon for further recommendations or treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
- •Age from 18 to 79 years
排除标准
- •Unclassified Inflammatory Bowel Disease
- •Diarrhea (> 3 bowel movements/day) with rectal bleeding at enrollment
- •Prior full proctectomy
- •Inability to collect the biological samples
- •Inability to complete the questionnaire
- •Refusal to sign the informed consent
结局指标
主要结局
Prevalence (number/percentage) of HPV infection in oral and anal samples
时间窗: Up to 12 months
PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV.
Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples
时间窗: Up to 12 months
Cytology changes will be reported according to the Bethesda classification.
次要结局
- Multivariate analysis to identify risk factors for HPV infection in oral and anal samples.(Up to 12 months)