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NCT02862795 Clinical Trial

Human Papillomavirus Anal Infection

HPV Infection Clinical Trial

— PAPILLAN  

Official title:
Human PapillomaVirus (HPV) Anal Infection: Study of Prevalence and Risk Factors Among 1000 Patients Benefiting From a Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02862795
Other study ID # API/2012/34
Secondary ID
Status Completed
Phase N/A
First received August 4, 2016
Last updated August 10, 2016
Start date April 2012
Est. completion date June 2016

Study information
Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• HPV detection in anal canal samples
Additional anal taking during the colonoscopy with cytobrush

Locations
Country Name City State
France Centre Hospitalier Régional Universitaire de Besançon Besançon
France Centre Hospitalier Intercommunal de la Haute Saône Vesoul

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary anal canal HPV infection at inclusion (the day of colonoscopy) No
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