Human Papillomavirus Anal Infection (PAPILLAN)
August 10, 2016 updated by: Centre Hospitalier Universitaire de Besancon
Human PapillomaVirus (HPV) Anal Infection: Study of Prevalence and Risk Factors Among 1000 Patients Benefiting From a Colonoscopy
Human papillomavirus (HPV) are involved in up to 95 % of anal canal neoplastic lesions.
Little is known about HPV carriage in anal canal previous to cancer occurrence in the population and pre-neoplastic lesions, and their risk factors.
PAPILLAN is a prospective study that aims to study HPV infection (HPV low grade and high grade genotypes) prevalence in anal canal in a population non selected by its HIV status.
In that purpose patients are prospectively recruited in a french university hospital gastroenterology unit and anal smears are collected during a colonoscopy with cytobrush.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Besançon, France, 25030
- Centre Hospitalier Régional Universitaire de Besançon
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Vesoul, France, 70014
- Centre Hospitalier Intercommunal de la Haute Saône
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients > 18 years
- patients undergoing colonoscopy under general anesthesia for any purpose
- signed written consent
Exclusion Criteria:
- age under 18
- Absence of written consent.
- patients incapable of giving consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: HPV detection in anal canal samples
|
Additional anal taking during the colonoscopy with cytobrush
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
anal canal HPV infection
Time Frame: at inclusion (the day of colonoscopy)
|
at inclusion (the day of colonoscopy)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 10, 2016
First Posted (Estimate)
August 11, 2016
Study Record Updates
Last Update Posted (Estimate)
August 11, 2016
Last Update Submitted That Met QC Criteria
August 10, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- API/2012/34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.