Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by University of Pittsburgh.
NCT01364896 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 46 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT01364896 record still lists
NCT01364896 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 46 participants, a relatively small participant target.
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01890590 · 46 participants · NA
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
- NCT03191149 · 46 participants · Phase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
- NCT03510208 · 46 participants · Phase 1
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
- NCT04048278 · 46 participants · Early Phase 1
Lidocaine Infusion in Pancreatic Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia