Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01860963

Acronym

ADIBD

Enrollment

310

Registered

2013-05-23

Start date

2010-01-31

Completion date

2013-06-30

Last updated

2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Squamous Intraepithelial Lesion (ASIL), HPV DNA

Keywords

ASIL, Anal dysplasia, IBD, HPV DNA

Brief 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.

Detailed 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.

Interventions

PROCEDUREAnal 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Presence of high risk HPV and/or abnormal cytology	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026