Anal Human Papillomavirus in Inflammatory Bowel Disease Study (Anal HPV & IBD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01364896
First received: May 26, 2011
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Inflammatory Bowel Disease (IBD)
Ulcerative Colitis (UC)
Crohn's Disease (CD)
Anal Human Papillomavirus
Procedure: Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Anal Human Papillomavirus (HPV) Infection in the University of Pittsburgh Inflammatory Bowel Disease (IBD) Cohort Study

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Presence or absence of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]
    As this is an observational cohort study there will be no blind. Simple comparisons will be made between the number and quantification of HPV types, number of high-grade dysplastic lesions, and grade of cytology swabs for each study participant at the two time points. This pilot study is not powered to identify differences in any of the parameters measured at the two time points, but will give an indication whether the hypotheses are substantiated and may subsequently be verified in a definitive study.

  • Quantification of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]
  • Anal cytology grade (normal, ASC-US, ASC-H, LSIL, HSIL, cancer) [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]
  • Anal biopsy grade (normal, AIN-1, AIN-2/AIN-3, cancer) [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]
  • Number of discrete high-grade anal dysplasia lesions [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Hide Detailed Description

Detailed Description:

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:

  • Medical/medication history.
  • Physical exam as per standard of care
  • Females of reproductive potential will give a urine sample for a pregnancy test. This test must be negative.
  • An anal Pap test for abnormal cells. The researcher will insert a swab (similar to a Q-tip) into the anus. The end of the swab will be rubbed against the skin inside the anus.
  • An anal swab to test for HPV (using the same method as the anal Pap)
  • Female participants will also have a vaginal swab for HPV. This may be self taken, or taken by a clinician.
  • An exam of the anus and genital area for any lesions or masses.
  • A rectal exam with a finger to feel for any abnormalities.
  • An anal exam called high resolution anoscopy (HRA) that uses a special microscope and dyes to examine the anus for abnormal areas. A lubricated plastic speculum will be inserted into the anus. Then, a swab moistened with acetic acid is placed in the anus so that abnormal areas will be visible. A colposcope will be used to view the skin inside the anus. A biopsy, with or without iodine for visualization of the abnormal areas, may be taken if any lesions have the appearance of high-grade anal dysplasia or other abnormal findings.

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:

  • Medical/medication history
  • Physical exam as per standard of care
  • Females of reproductive potential will give a urine or 5ml blood sample] for a pregnancy test. This test must be negative.
  • Anal Pap test for abnormal cells
  • Anal swab for HPV
  • Females participants will also have a vaginal swab for HPV
  • An exam of the anus and genital area for any lesions, tenderness or masses
  • A rectal exam to feel for any abnormalities
  • High-resolution anoscopy (HRA). A biopsy, with or without iodine for visualization of the abnormal areas, may be taken if any lesions have the appearance of high-grade anal dysplasia or other abnormal findings.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous or current treatment with a biological agent for inflammatory bowel disease
  2. 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
  3. 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
  4. For female subjects, currently breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364896

Contacts
Contact: Jonathan Baker, PA-C (412) 383-1675 bakerjr2@upmc.edu
Contact: Elena Infante 412) 864-7516 emi9@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Carol Oriss, RN, BSN    412-383-1434    orissca@upmc.edu   
Principal Investigator: Ross Cranston, MD         
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ross Cranston, M.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01364896     History of Changes
Other Study ID Numbers: 38458
Study First Received: May 26, 2011
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Non-corticosteroid immunosuppressive agent

Additional relevant MeSH terms:
Colitis, Ulcerative
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014