Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Presence of high risk HPV and/or abnormal cytology
研究概览
简要总结
This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.
详细描述
IBD patients attending the Stanford Inflammatory Bowel Disease (IBD) clinic and age-matched healthy controls are screened for eligibility. Informed consent is obtained for eligible subjects. An anonymous self-administered questionnaire is administered to assess risk factors for HPV. For IBD patients, information regarding IBD diagnosis and treatment is obtained.
An anal pap smear is performed at the time of a clinic visit or at the time of an already scheduled colonoscopy. Samples are collected and processed at Stanford pathology where a blinded pathologist reads all specimens. Human Papillomavirus (HPV) DNA testing is performed on all specimens. All patients with anal squamous intraepithelial lesion (ASIL) are referred to a colorectal surgeon for further recommendations or treatment, which includes a high-resolution anoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old
排除标准
- •History of HPV vaccination
- •Pregnancy
- •Other immunosuppressed states (i.e. systemic lupus erythematosus, rheumatoid arthritis, cancer, Human Immunodeficiency Virus (HIV), transplant)
- •IBD patients who don't meet immunosuppression/non-immunosuppression criteria
- •Inability to obtain informed consent from patient
- •Previous diagnosis of ASIL or anal/rectal cancer
研究组 & 干预措施
IBD patients on immunosuppression
Patients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included.
干预措施: Anal Pap smear and HPV DNA testing (Procedure)
IBD patients off immunosuppressants
Patients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included.
干预措施: Anal Pap smear and HPV DNA testing (Procedure)
Healthy controls
Age-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements.
干预措施: Anal Pap smear and HPV DNA testing (Procedure)
结局指标
主要结局
Presence of high risk HPV and/or abnormal cytology
时间窗: 1 day
次要结局
未报告次要终点