HPV InfectionPAPILLANNCT02862795
Human Papillomavirus Anal Infection
A study testing HPV detection in anal canal samples in people with HPV Infection, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV Infection
- What is being tested?
- HPV detection in anal canal samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients > 18 years
- patients undergoing colonoscopy under general anesthesia for any purpose
- signed written consent
Who cannot join
- age under 18
- Absence of written consent.
- patients incapable of giving consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Régional Universitaire de Besançon
Besançon, 25030
Centre Hospitalier Intercommunal de la Haute Saône
Vesoul, 70014
About this study
Official title: 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.
- Conditions
- HPV Infection
- Being tested
- HPV detection in anal canal samples
- Keywords
- colonoscopy
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV detection in anal canal samplesProcedure or surgery
Additional anal taking during the colonoscopy with cytobrush
| Study group | Role | What they receive |
|---|---|---|
| HPV detection in anal canal samples | Other | Not described Receives: Procedure: HPV detection in anal canal samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
anal canal HPV infection
Measured: at inclusion (the day of colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startApr 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862795
- Sponsor's protocol ID
- API/2012/34
- Acronym
- PAPILLAN
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human PapillomaVirus (HPV) Anal Infection: Study of Prevalence and Risk Factors Among 1000 Patients Benefiting From a Colonoscopy
- ClinicalTrials.gov ID
- NCT02862795
- Acronym / sponsor ID
- PAPILLAN / API/2012/34
- Conditions
- HPV Infection
- Keywords
- colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV detection in anal canal samples | Other | Procedure: HPV detection in anal canal samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients > 18 years
- patients undergoing colonoscopy under general anesthesia for any purpose
- signed written consent
Key exclusion criteria (3 listed)
- age under 18
- Absence of written consent.
- patients incapable of giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV detection in anal canal samplesAdditional anal taking during the colonoscopy with cytobrush | Procedure or surgery | HPV detection in anal canal samples |
Primary outcome
anal canal HPV infection
Time frame: at inclusion (the day of colonoscopy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV detection in anal canal samples in people with HPV Infection, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anal canal HPV infection (time frame: at inclusion (the day of colonoscopy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.