Back to resultsHuman Papillomavirus Anal Infection (PAPILLAN)
Primary Purpose
HPV Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HPV detection in anal canal samples
Sponsored by
About this trial
This is an interventional prevention trial for HPV Infection focused on measuring colonoscopy
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Régional Universitaire de Besançon
- Centre Hospitalier Intercommunal de la Haute Saône
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HPV detection in anal canal samples
Arm Description
Outcomes
Primary Outcome Measures
anal canal HPV infection
Secondary Outcome Measures
Full Information
NCT ID
NCT02862795
First Posted
August 4, 2016
Last Updated
August 10, 2016
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02862795
Brief Title
Human Papillomavirus Anal Infection
Acronym
PAPILLAN
Official Title
Human PapillomaVirus (HPV) Anal Infection: Study of Prevalence and Risk Factors Among 1000 Patients Benefiting From a Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection
Keywords
colonoscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV detection in anal canal samples
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
HPV detection in anal canal samples
Intervention Description
Additional anal taking during the colonoscopy with cytobrush
Primary Outcome Measure Information:
Title
anal canal HPV infection
Time Frame
at inclusion (the day of colonoscopy)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Hospitalier Intercommunal de la Haute Saône
City
Vesoul
ZIP/Postal Code
70014
Country
France
12. IPD Sharing Statement
Learn more about this trial
Human Papillomavirus Anal Infection
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