Anal Human Papillomavirus in Inflammatory Bowel Disease Study
Completed
Conditions studied: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn's Disease (CD), Anal Human Papillomavirus
In brief
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.
Key facts
- Study ID
- NCT01364896
- Run by
- University of Pittsburgh
- People needed
- 46
- Starts
- 2011-06-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2019-05-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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