NCT02862795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

4.2 years

First QC Date

August 4, 2016

Last Update Submit

August 10, 2016

Conditions

HPV Infection

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

  • anal canal HPV infection

    at inclusion (the day of colonoscopy)

Study Arms (1)

HPV detection in anal canal samples

OTHER
Procedure: HPV detection in anal canal samples

Interventions

HPV detection in anal canal samplesPROCEDURE

Additional anal taking during the colonoscopy with cytobrush

HPV detection in anal canal samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients \> 18 years
  • patients undergoing colonoscopy under general anesthesia for any purpose
  • signed written consent

You may not qualify if:

  • age under 18
  • Absence of written consent.
  • patients incapable of giving consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, 25030, France

Location

Centre Hospitalier Intercommunal de la Haute Saône

Vesoul, 70014, France

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 11, 2016

Study Start

April 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

FR(2)