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OpenTrials
Completed

NCT Number: NCT01860963

Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Digestive Health Center

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anal Pap smear and HPV DNA testing

Procedure

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

Primary outcomes

  1. Presence of high risk HPV and/or abnormal cytology

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: ADIBD

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 23, 2013
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.