NCT02774538CompletedNot Applicable
Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV
Institut de Cancérologie de Lorraine6 sites in 1 country165 target enrollmentStarted: May 11, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 165
- Locations
- 6
- Primary Endpoint
- Agreement between oral and cervical HPV infection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Agreement between oral and cervical HPV infection
Time Frame: 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 Outcomes
- 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)
- Frequency of newly positive women with oral HPV infection(up to 18 months)
- Description of all HPV genotypes found in women with HPV infection at both sites(up to 6 months)
- Oral HPV risk factors(up to 6 months)
- Agreement between full and partial oral and cervical HPV genotypes(up to 6 months)
Investigators
Study Sites (6)
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