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

Human Papillomavirus-Related Cervical Carcinoma Clinical Trial

— PAPILLOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774538
• Other study ID #: 2015-A00594-45
• Status: Completed
• Phase: N/A
• Start date: May 11, 2016
• Est. completion date: April 2022

Study information

• Verified date: December 2022
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus-Related Cervical Carcinoma
• Infections
• Papillomavirus Infections

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Nord Franche-Comté	Belfort
France	CHRU Besançon	Besançon
France	Maternité Régionale Universitaire de Nancy	Nancy
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of women with oral HPV infection in women with primary cervical HPV infection		up to 6 months
Secondary	Proportion of women with oral high risk HPV infection		up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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