Human Papillomavirus-Related Cervical Carcinoma
Conditions
Keywords
Cervical HPV infection, Oral HPV infection, Sexually transmitted infection
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.
Interventions
OTHERAgreement 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.
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
France
Outcome results
None listed