Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-11

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Papillomavirus-Related Cervical Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Experimental arm

Group Type OTHER

Agreement between oral and cervical HPV infection

Intervention Type OTHER

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.

Interventions

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Agreement between oral and cervical HPV infection

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No