Human Papillomavirus-Related Cervical CarcinomaPAPILLORNCT02774538
Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort
A study testing Agreement between oral and cervical HPV infection in people with Human Papillomavirus-Related Cervical Carcinoma, run by Institut de Cancérologie de Lorraine at 4 sites in France.
Trial summary
Human papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and they are associated with genital and oral diseases. Agreement between cervical and oral HPV infection has been described from a small group of patient. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Papillomavirus-Related Cervical Carcinoma
- What is being tested?
- Agreement between oral and cervical HPV infection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 4 sitesFrance
- Study dates
- 11 May 2016to Apr 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic proven of cervical intraepithelial neoplasia or carcinoma in situ (CIS) or invasive cervical cancer or a Pap smear on which at least one HPV has been detected
- Patients not vaccinated against HPV
- Age >18 years
- EOCG performance status ≤ 3
- Patient must be affiliated to a social security system
- Ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study
Who cannot join
- Patients vaccinated against HPV
- Pregnant woman over 10 weeks
- Patient who underwent head and neck radiotherapy dating less than one year
- Patients deprived of liberty or under supervision
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Nord Franche-Comté
Belfort
CHRU Besançon
Besançon
Maternité Régionale Universitaire de Nancy
Nancy, 54000
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV
Human papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and they are associated with genital and oral diseases.
Agreement between cervical and oral HPV infection has been described from a small group of patient. Our study, performed on a greater number of patients, will provide a good estimation of this link, between cervical and oral infection, in a French population of women with a primary cervical HPV infection.
- Being tested
- Agreement between oral and cervical HPV infection
- Keywords
- Cervical HPV infection, Oral HPV infection, Sexually transmitted infection
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agreement between oral and cervical HPV infectionOther
A total of 165 women will have a Pap test and an oral brushing performed on the day of inclusion. Risk factors for oral HPV infection will be defined using a self-administered survey summarizing the demographics and sexual behaviors.
A second oral brushing up to 18 months will be performed during a standard follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Other | Not described Receives: Other: Agreement between oral and cervical HPV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between oral and cervical HPV infection
Agreement between oral and cervical HPV infection is defined by the presence of at least one identical genotype HPV in both sites in the same wife. All genotypes found in the oral and cervical area will be considered.
Measured: up to 6 months
Secondary outcomes (7)
Agreement between full and partial oral and cervical HPV genotypes
Agreement between oral and cervical HPV genotypes is considered as complete if the same HPV genotypes were detected on both sites. Agreement between oral and cervical HPV genotypes is considered as partial when at least one but not all HPV genotypes were detected at both sites.
Measured: up to 6 months
Proportion of women with oral HPV infection in women with primary cervical HPV infection
Measured: up to 6 months
Proportion of women with oral high risk HPV infection
Measured: up to 6 months
Description of all HPV genotypes found in women with HPV infection at both sites
All genotypes found in the oral and cervical area will be described.
Measured: up to 6 months
Oral HPV risk factors
The following oral HPV risk factors will be analyzed: smoking, regular alcohol consumption, number of sexual partners, sexual risk behaviors.
Measured: up to 6 months
Persistence and clearance of oral HPV infection
The persistence of HPV infection will be defined by the detection of the same genotype of oral HPV between the two tests.
The clearance of HPV infection will be defined by a positive oral HPV infection at baseline and a negative oral HPV infection up to 18 months.
Measured: up to 18 months
Frequency of newly positive women with oral HPV infection
Women with no HPV infection at baseline and positive HPV infection at 18 months will be considered as newly positive women.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start11 May 2016
- Primary completionDec 2020
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related Cervical CarcinomaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GUILLET Julie, Dr, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774538
- Sponsor's protocol ID
- 2015-A00594-45
- Acronym
- PAPILLOR
- Status last verified
- Dec 2022
- First submitted
- 3 May 2016
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV
- ClinicalTrials.gov ID
- NCT02774538
- Acronym / sponsor ID
- PAPILLOR / 2015-A00594-45
- Keywords
- Cervical HPV infection, Oral HPV infection, Sexually transmitted infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 11 May 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 17 May 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 papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and they are associated with genital and oral diseases.
Agreement between cervical and oral HPV infection has been described from a small group of patient. Our study, performed on a greater number of patients, will provide a good estimation of this link, between cervical and oral infection, in a French population of women with a primary cervical HPV infection.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Other | Other: Agreement between oral and cervical HPV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologic proven of cervical intraepithelial neoplasia or carcinoma in situ (CIS) or invasive cervical cancer or a Pap smear on which at least one HPV has been detected
- Patients not vaccinated against HPV
- Age >18 years
- EOCG performance status ≤ 3
- Patient must be affiliated to a social security system
Key exclusion criteria (4 listed)
- Patients vaccinated against HPV
- Pregnant woman over 10 weeks
- Patient who underwent head and neck radiotherapy dating less than one year
- Patients deprived of liberty or under supervision
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 |
|---|---|---|
| Agreement between oral and cervical HPV infectionA total of 165 women will have a Pap test and an oral brushing performed on the day of inclusion. Risk factors for oral HPV infection will be defined using a self-administered survey summarizing the demographics and sexual behaviors. A second oral brushing up to 18 months will be performed during a standard follow-up visit. | Other | Experimental arm |
Primary outcome
Agreement between oral and cervical HPV infection
Time frame: up to 6 months
Agreement between oral and cervical HPV infection is defined by the presence of at least one identical genotype HPV in both sites in the same wife. All genotypes found in the oral and cervical area will be considered.
7 secondary outcomes
Agreement between full and partial oral and cervical HPV genotypes
Time frame: up to 6 months
Proportion of women with oral HPV infection in women with primary cervical HPV infection
Time frame: up to 6 months
Proportion of women with oral high risk HPV infection
Time frame: up to 6 months
Description of all HPV genotypes found in women with HPV infection at both sites
Time frame: up to 6 months
Oral HPV risk factors
Time frame: up to 6 months
Persistence and clearance of oral HPV infection
Time frame: up to 18 months
Frequency of newly positive women with oral HPV infection
Time frame: up to 18 months
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 19 Dec 2022.
- Individual participant dataSharing planned: No
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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.
GUILLET Julie, Dr principal investigator
Institut de Cancérologie de Lorraine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agreement between oral and cervical HPV infection in people with Human Papillomavirus-Related Cervical Carcinoma, run by Institut de Cancérologie de Lorraine at 4 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 6 inclusion and 4 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 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Agreement between oral and cervical HPV infection (time frame: up to 6 months). 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 19 Dec 2022.