Anal Human Papillomavirus in Inflammatory Bowel Disease Study

NCT01364896 | Completed Results

• 1 other identifier: 38458
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational cohort study with two time points (baseline and after at least 6 months of treatment with a non-corticosteroid immunosuppressive agent for inflammatory bowel disease (IBD)). Approximately 40 participants, both male and female, 18 years of age and older will be recruited from the Pittsburgh IBD Cohort. Participants will have a histological diagnosis of IBD (Ulcerative Colitis (UC) or Crohn's Disease (CD)) and will be attending for colonoscopy prior to starting a non-corticosteroid immunosuppressive agent as part of standard medical care. Immediately following the colonoscopy, an anal exam will be performed for research purposes to include:

1. 1.Perianal inspection
2. 2.Anal canal HPV swab
3. 3.Anal cytology
4. 4.Digital anal examination
5. 5.High resolution anoscopy (HRA) and biopsy of all lesions with visual criteria consistent with high-grade anal dysplasia
6. 6.For female participants a self- or clinician-taken vaginal swab for HPV typing.

Conditions

Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn's Disease (CD); Anal Human Papillomavirus

Keywords

Non-corticosteroid immunosuppressive agent

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types

  Anal (and vaginal for female participants) HPV PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58) using the SYBR-Green-based real-time PCR assay with a reverse line blot assay for genotyping of HPV in the positive samples and Taqman probe-based real-time PCR assays for quantification of individual HPV subtypes

  Baseline and 6 to 12 months

• Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58

  Baseline and 6 to 12 months

• Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)

  High-resolution anoscopy with anal cytology testing

  Baseline and 6 to 12 months

• Number of Participants Who Had One or More Anal Biopsies

  High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria

  Baseline and 6 to 12 months

• Number of Participants With High-grade Anal Dysplasia Lesions

  High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria

  Baseline and 6 to 12 months

Study Arms (1)

Inflammatory bowel disease, Immunosuppressive agent

Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent

Procedure: Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples

Interventions

Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples PROCEDURE

Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have: 1. Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58) 2. High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria 3. Anal cytology testing

Inflammatory bowel disease, Immunosuppressive agent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent

You may qualify if:

• Previous biopsy proven inflammatory bowel disease (ulcerative colitis or Crohn's disease)
• Male or female over 18 years of age
• Able and willing to give informed consent in English
• Able and willing to provide locator information
• Planned commencement of a non-corticosteroid immunosuppressive agent for management of inflammatory bowel disease
• Sexually active
• Female subjects of reproductive potential must agree to use an acceptable method of birth control while on this study.

You may not qualify if:

• Previous or current treatment with a biological agent for inflammatory bowel disease
• Any other condition or prior therapy that, in the opinion of the investigator, would make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease
• For female subjects of reproductive potential, current pregnancy, pregnancy within the 90 days prior to study entry, or planning to become pregnant within 12 months after study entry
• For female subjects, currently breastfeeding

Sponsors & Collaborators

• University of Pittsburgh: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood, anal swabs, vaginal swabs, high resolution anoscopy (HRA), anal biopsy samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Results Point of Contact

• Title: Ross Cranston
• Organization: University of Pittsburgh

rdc27@pitt.edu

412-383-1675

Study Officials

• Ross Cranston, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 21, 2019
• Results First Posted: March 9, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)