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

NCT02774538 | Completed

• 1 other identifier: 2015-A00594-45
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 4

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.

Conditions

Human Papillomavirus-Related Cervical Carcinoma

Keywords

Cervical HPV infection; Oral HPV infection; Sexually transmitted infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Agreement between full and partial oral and cervical HPV genotypes

  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

  up to 6 months

• Oral HPV risk factors

  up to 6 months

Study Arms (1)

Experimental arm

OTHER

Other: Agreement between oral and cervical HPV infection

Interventions

Agreement between oral and cervical HPV infection OTHER

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (4)

Hôpital Nord Franche-Comté

Belfort, France

Location

CHRU Besançon

Besançon, France

Location

Maternité Régionale Universitaire de Nancy

Nancy, 54000, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GUILLET Julie, Dr

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 17, 2016
• Study Start: May 11, 2016
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)