Clinical trial NCT02774538: Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort
Official title: Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus-Related Cervical Carcinoma
Keywords: Cervical HPV infection
Oral HPV infection
Sexually transmitted infection
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Agreement between oral and cervical HPV infection
timeFrame: up to 6 months
Secondary outcomes:
measure: Agreement between full and partial oral and cervical HPV genotypes
timeFrame: up to 6 months
measure: Proportion of women with oral HPV infection in women with primary cervical HPV infection
timeFrame: up to 6 months
measure: Proportion of women with oral high risk HPV infection
timeFrame: up to 6 months
measure: Description of all HPV genotypes found in women with HPV infection at both sites
timeFrame: up to 6 months
measure: Oral HPV risk factors
timeFrame: up to 6 months
measure: Persistence and clearance of oral HPV infection
timeFrame: up to 18 months
measure: Frequency of newly positive women with oral HPV infection
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hôpital Nord Franche-Comté
city: Besançon
country: France
facility: CHRU Besançon
city: Nancy
country: France
facility: Maternité Régionale Universitaire de Nancy
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: GUILLET Julie, Dr
role: PRINCIPAL_INVESTIGATOR
References: