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
Results First Received: December 3, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Inflammatory Bowel Disease (IBD)
Ulcerative Colitis (UC)
Crohn's Disease (CD)
Anal Human Papillomavirus
Intervention: Procedure: Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

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

Participant Flow:   Overall Study
    Inflammatory Bowel Disease, Immunosuppressive Agent  
STARTED     46  
COMPLETED     46  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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

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

Baseline Measures
    Inflammatory Bowel Disease, Immunosuppressive Agent  
Number of Participants  
[units: participants]
  46  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     46  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  32  (8)  
Gender  
[units: participants]
 
Female     21  
Male     25  
Region of Enrollment  
[units: participants]
 
United States     46  
Number of participants with Crohn's Disease  
[units: participants]
  31  
Number of participants with Ulcerative Colitis  
[units: participants]
  14  
Number of participants with Indeterminate Colitis  
[units: participants]
  1  



  Outcome Measures
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1.  Primary:   Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types   [ Time Frame: Baseline and 6 to 12 months ]

2.  Primary:   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 ]

3.  Primary:   Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)   [ Time Frame: Baseline and 6 to 12 months ]

4.  Primary:   Number of Participants Who Had One or More Anal Biopsies   [ Time Frame: Baseline and 6 to 12 months ]

5.  Primary:   Number of Participants With High-grade Anal Dysplasia Lesions   [ Time Frame: Baseline and 6 to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ross Cranston
Organization: University of Pittsburgh
phone: 412-383-1675
e-mail: rdc27@pitt.edu



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