N/A
N=46
Anal Human Papillomavirus in Inflammatory Bowel Disease Study
Inflammatory Bowel Disease (IBD) · Ulcerative Colitis (UC) · Crohn's Disease (CD) · Anal Human Papillomavirus
Bottom Line
View on ClinicalTrials.gov: NCT01364896 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types — 41; 16; 25 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types |
41; 16; 25 | — |
| PRIMARY Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58 |
6.6; 23.9; 65.2; 2.2; 2.2; 0 | — |
| PRIMARY Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer) |
21; 28; 4; 24 | — |
| PRIMARY Number of Participants Who Had One or More Anal Biopsies |
33 | — |
| PRIMARY Number of Participants With High-grade Anal Dysplasia Lesions |
28 | — |
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. Perianal inspection
2. Anal canal HPV swab
3. Anal cytology
4. Digital anal examination
5. High resolution anoscopy (HRA) and biopsy of all lesions with visual criteria consistent with high-grade anal dysplasia
6. For female participants a self- or clinician-taken vaginal swab for HPV typing.
These procedures will be repeated at routine colonoscopy following at least 6 months but within 12 months of non-corticosteroid immunosuppressive treatment.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01364896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.