Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort
- Conditions
- Human Papillomavirus-Related Cervical Carcinoma
- Interventions
- Other: Agreement between oral and cervical HPV infection
- Registration Number
- NCT02774538
- Lead Sponsor
- Institut de Cancérologie de Lorraine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 165
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental arm Agreement between oral and cervical HPV infection -
- Primary Outcome Measures
Name Time Method Agreement between oral and cervical HPV infection 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.
- Secondary Outcome Measures
Name Time Method Proportion of women with oral HPV infection in women with primary cervical HPV infection up to 6 months Proportion of women with oral high risk HPV infection up to 6 months Persistence and clearance of oral HPV infection up to 18 months 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.Frequency of newly positive women with oral HPV infection up to 18 months Women with no HPV infection at baseline and positive HPV infection at 18 months will be considered as newly positive women.
Description of all HPV genotypes found in women with HPV infection at both sites up to 6 months All genotypes found in the oral and cervical area will be described.
Oral HPV risk factors up to 6 months The following oral HPV risk factors will be analyzed: smoking, regular alcohol consumption, number of sexual partners, sexual risk behaviors.
Agreement between full and partial oral and cervical HPV genotypes up to 6 months 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.
Trial Locations
- Locations (4)
Hôpital Nord Franche-Comté
🇫🇷Belfort, France
CHRU Besançon
🇫🇷Besançon, France
Maternité Régionale Universitaire de Nancy
🇫🇷Nancy, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre-lès-Nancy, France