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NCT01364896 · ClinicalTrials.gov registry record
Anal Human Papillomavirus in Inflammatory Bowel Disease Study
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 46
- Enrollment target
NCT01364896 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 46 participants.
The verdict
NCT01364896 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 46 participants
- Enrollment target
Study Summary
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.
Interventions
- PROCEDURE Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01364896
The ClinicalTrials.gov registry entry for NCT01364896 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples is the first listed.
NCT01364896 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01364896 about?
NCT01364896 is a clinical study titled "Anal Human Papillomavirus in Inflammatory Bowel Disease Study". 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...
What is the current status of trial NCT01364896?
This trial is currently completed. The enrollment target is 46 participants. The study started on 2011-06. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01364896?
The interventions under investigation include: Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples (PROCEDURE).
Who is sponsoring clinical trial NCT01364896?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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