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Completed

NCT Number: NCT02774538

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

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.

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Key information

Conditions

Human Papillomavirus-Related Cervical Carcinoma Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Nord Franche-Comté, Belfort, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Proportion of women with oral HPV infection in women with primary cervical HPV infection

    Time frame: up to 6 months

  3. Proportion of women with oral high risk HPV infection

    Time frame: up to 6 months

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: PAPILLOR

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
May 17, 2016
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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