Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort (PAPILLOR)

Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV

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 Overview

• Status: Completed
• Conditions: Human Papillomavirus-Related Cervical Carcinoma
• Intervention / Treatment: Other: Agreement between oral and cervical HPV infection

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Belfort, France
    • Hôpital Nord Franche-Comté
  • Besançon, France
    • CHRU Besançon
  • Nancy, France, 54000
    • Maternité Régionale Universitaire de Nancy
  • Vandoeuvre-lès-Nancy, France, 54500
    • Institut de Cancérologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 6 months
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	All genotypes found in the oral and cervical area will be described.	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.	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.	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.	up to 18 months

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Principal Investigator: GUILLET Julie, Dr, Institut de Cancérologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Sexually transmitted infection; Cervical HPV infection; Oral HPV infection
• Additional Relevant MeSH Terms: Virus Diseases; DNA Virus Infections; Tumor Virus Infections; Infections; Papillomavirus Infections
• Other Study ID Numbers: 2015-A00594-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No