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Characterization of Anal Human Papillomavirus (HPV) Infection in the University of Pittsburgh Inflammatory Bowel Disease (IBD) Cohort Study


N/A
18 Years
65 Years
Open (Enrolling)
Both
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn's Disease (CD), Anal Human Papillomavirus

Thank you

Trial Information

Characterization of Anal Human Papillomavirus (HPV) Infection in the University of Pittsburgh Inflammatory Bowel Disease (IBD) Cohort Study


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Presence or absence of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58

Outcome Description:

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.

Outcome Time Frame:

Baseline and 6 to 12 months

Safety Issue:

No

Principal Investigator

Ross Cranston, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

38458

NCT ID:

NCT01364896

Start Date:

June 2011

Completion Date:

December 2013

Related Keywords:

  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis (UC)
  • Crohn's Disease (CD)
  • Anal Human Papillomavirus
  • Non-corticosteroid immunosuppressive agent
  • Colitis
  • Colitis, Ulcerative
  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Intestinal Diseases
  • Ulcer

Name

Location

University of PittsburghPittsburgh, Pennsylvania  15261