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

Institut de Cancérologie de Lorraine165 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

165

Conditions

Human Papillomavirus-Related Cervical Carcinoma

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Hôpital Nord Franche-Comté

Belfort, France

CHRU Besançon

Besançon, France

Maternité Régionale Universitaire de Nancy

Nancy, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Outcomes

Primary Outcomes

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.

Time frame: up to 6 months

Secondary Outcomes

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.

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

All genotypes found in the oral and cervical area will be described.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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