An interventional study of Agreement between oral and cervical HPV infection in Human Papillomavirus-Related Cervical Carcinoma, sponsored by Institut de Cancérologie de Lorraine. Completed at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-19.
Sponsored by Institut de Cancérologie de Lorraine · Not applicable, Interventional, and Health services research
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 165 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Other: Agreement 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.
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
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.
Time frame: up to 18 months
Frequency of newly positive women with oral HPV infection
Women with no HPV infection at baseline and positive HPV infection at 18 months will be considered as newly positive women.
Time frame: up to 18 months
Plan to share: No
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Institut de Cancérologie de Lorraine