Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

HPV DNA Clinical Trial

— ADIBD  

Official title:

Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860963
• Other study ID #: MW-16467
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: September 30, 2013
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Anal Squamous Intraepithelial Lesion (ASIL)
• HPV DNA
• Inflammatory Bowel Diseases

Intervention

Procedure:
• Anal Pap smear and HPV DNA testing
Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.

Locations

Country	Name	City	State
United States	Stanford Digestive Health Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of high risk HPV and/or abnormal cytology		1 day	No