Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort (PAPILLOR)
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|ClinicalTrials.gov Identifier: NCT02774538|
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : June 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus-Related Cervical Carcinoma||Other: Agreement between oral and cervical HPV infection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV|
|Actual Study Start Date :||May 11, 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||November 2021|
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 [ 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.
- Agreement between full and partial oral and cervical HPV genotypes [ Time Frame: 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.
- 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 [ Time Frame: up to 6 months ]All genotypes found in the oral and cervical area will be described.
- Oral HPV risk factors [ Time Frame: up to 6 months ]The following oral HPV risk factors will be analyzed: smoking, regular alcohol consumption, number of sexual partners, sexual risk behaviors.
- Persistence and clearance of oral HPV infection [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774538
|Contact: MERLIN Jean Louis, PharmaD||+ 33 3 83 59 83 email@example.com|
|Contact: HUIN SCHOHN Cécile, phD||+ 33 3 83 59 86 firstname.lastname@example.org|
|Maternité Régionale Universitaire de Nancy||Recruiting|
|Nancy, France, 54000|
|Contact: Judlin Philippe, Pr email@example.com|
|Institut de Cancérologie de Lorraine||Recruiting|
|Vandoeuvre-lès-Nancy, France, 54500|
|Contact: Guillet Julie, Dr firstname.lastname@example.org|
|Principal Investigator:||GUILLET Julie, Dr||Institut de Cancérologie de Lorraine|