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

This study has been completed.
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: March 9, 2016
Last verified: March 2016
  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:
  • Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer) [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]
    High-resolution anoscopy with anal cytology testing

  • Number of Participants Who Had One or More Anal Biopsies [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]
    High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria

  • Number of Participants With High-grade Anal Dysplasia Lesions [ Time Frame: Baseline and 6 to 12 months ] [ Designated as safety issue: No ]
    High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria


Biospecimen Retention:   Samples Without DNA
Venous blood, anal swabs, vaginal swabs, high resolution anoscopy (HRA), anal biopsy samples

Enrollment: 46
Study Start Date: June 2011
Study Completion Date: December 2015
Primary Completion Date: January 2014 (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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ross Cranston, M.D. University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01364896     History of Changes
Other Study ID Numbers: 38458 
Study First Received: May 26, 2011
Results First Received: December 3, 2015
Last Updated: March 9, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on December 02, 2016