An observational study in Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC) and Crohn's Disease (CD), sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by University of Pittsburgh · Observational
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:
These procedures will be repeated at routine colonoscopy following at least 6 months but within 12 months of non-corticosteroid immunosuppressive treatment.
Treatment of IBD relies on disease modification by induction of relative immunosuppression with corticosteroids and latterly and increasingly, by the use of immunomodulators (azathioprine, mercaptopurine, methotrexate), biological agents such as anti tumor necrosis factor monoclonal antibodies (infliximab, adalimumab, certolizumab) or with a circulating receptor fusion protein (etanercept). These agents impair cell mediated immunity (CMI) and have been associated with increased rates of both tuberculosis and fungal infections in treated populations beyond that seen with corticosteroids alone. Following initial infection, HPV is controlled by CMI and manifestations of infection become increasingly clinically apparent when CMI is impaired due to for example HIV co-infection or systemic immunosuppression. There is appropriate concern in the IBD treatment community that the use of immunosuppression to modify disease course may lead to increased rates of HPV associated disease including warts, dysplasia and ultimately anogenital cancer above and beyond the established increased risk associated with IBD. In this context it is important to establish the prevalence of both HPV infection and anal dysplasia in patients with IBD before and after treatment with a non-steroid immunosuppressive agent. These data will help determine the need for HPV vaccination and/or anal dysplasia screening in patients with IBD.
VISIT 1 (Screening/Enrollment Visit): This visit will include:
Within 1 day after this visit, study staff will telephone the participant to ask about any side effects or health problems from the study procedures. If necessary, the participant may be asked to come to the clinic for a visit.
VISIT 2 (Final Visit): This visit will occur 6 to 12 months after the first visit. Prior to this visit, participant will be instructed to not have anal sex or insert anything into the anus, including enemas, for 24 hours before each study visit. This visit will include:
Within 1 day after this visit, study staff will telephone the participant to ask about any side effects or health problems from the study procedures. If necessary, the participant may be asked to come to the clinic for a visit.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 46 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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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
Exclusion Criteria:
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
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
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
Time frame: Baseline and 6 to 12 months
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 6 to 12 months
| Milestone | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Started | 46 |
| Completed | 46 |
| Not completed | 0 |
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
| participants | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Number of Participants with Anal HPV of Any Type | 41 |
| Number of Participants with Single Types | 16 |
| Number of Participants with Multiple Types | 25 |
| percentage of participants | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Percent of Participants with HPV type 6 | 6.6 |
| Percent of Participants with HPV type 11 | 23.9 |
| Percent of Participants with HPV type 16 | 65.2 |
| Percent of Participants with HPV type 18 | 2.2 |
| Percent of Participants with HPV type 31 | 2.2 |
| Percent of Participants with HPV type 33 | 0 |
| Percent of Participants with HPV type 45 | 23.9 |
| Percent of Participants with HPV type 52 | 0 |
| Percent of Participants with HPV type 58 | 2.2 |
| Percent of Females with Vaginal HPV | 90.5 |
High-resolution anoscopy with anal cytology testing
| participants | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Number of Participants with Abnormal Anal Cytology | 21 |
| Number of Participants with Anal Dysplasia | 28 |
| Number of Participants with HSIL | 4 |
| Number of Participants with LSIL | 24 |
High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
| participants | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Number of Participants Who Had One or More Anal Biopsies | 33 |
High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
| participants | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Number of Participants With High-grade Anal Dysplasia Lesions | 28 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inflammatory Bowel Disease, Immunosuppressive Agent | — | 0/45 (0%) | 0/45 (0%) |
| Age, Categorical(Participants) | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 46 |
| >=65 years | 0 |
| Age, Continuous(years) | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Mean | 32 ± 8 |
| Sex: Female, Male(Participants) | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Female | 21 |
| Male | 25 |
| Region of Enrollment(participants) | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| United States | 46 |
| Number of participants with Crohn's Disease(participants) | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Number | 31 |
| Number of participants with Ulcerative Colitis(participants) | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Number | 14 |
| Number of participants with Indeterminate Colitis(participants) | Inflammatory Bowel Disease, Immunosuppressive Agent |
|---|---|
| Number | 1 |
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