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

Primary Purpose

Human Papillomavirus-Related Cervical Carcinoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Agreement between oral and cervical HPV infection
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Papillomavirus-Related Cervical Carcinoma focused on measuring Cervical HPV infection, Oral HPV infection, Sexually transmitted infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Nord Franche-Comté
  • CHRU Besançon
  • Maternité Régionale Universitaire de Nancy
  • Institut de Cancérologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experimental arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Proportion of women with oral HPV infection in women with primary cervical HPV infection
Proportion of women with oral high risk HPV infection
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.
Oral HPV risk factors
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
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
Women with no HPV infection at baseline and positive HPV infection at 18 months will be considered as newly positive women.

Full Information

First Posted
May 3, 2016
Last Updated
December 16, 2022
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02774538
Brief Title
Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort
Acronym
PAPILLOR
Official Title
Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
April 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus-Related Cervical Carcinoma
Keywords
Cervical HPV infection, Oral HPV infection, Sexually transmitted infection

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Agreement between oral and cervical HPV infection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agreement between oral and cervical HPV infection
Description
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
Secondary Outcome Measure Information:
Title
Agreement between full and partial oral and cervical HPV genotypes
Description
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
Title
Proportion of women with oral HPV infection in women with primary cervical HPV infection
Time Frame
up to 6 months
Title
Proportion of women with oral high risk HPV infection
Time Frame
up to 6 months
Title
Description of all HPV genotypes found in women with HPV infection at both sites
Description
All genotypes found in the oral and cervical area will be described.
Time Frame
up to 6 months
Title
Oral HPV risk factors
Description
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
Title
Persistence and clearance of oral HPV infection
Description
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
Title
Frequency of newly positive women with oral HPV infection
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GUILLET Julie, Dr
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Nord Franche-Comté
City
Belfort
Country
France
Facility Name
CHRU Besançon
City
Besançon
Country
France
Facility Name
Maternité Régionale Universitaire de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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