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

I

Institut de Cancérologie de Lorraine

Status

Completed

Conditions

Human Papillomavirus-Related Cervical Carcinoma

Treatments

Other: Agreement between oral and cervical HPV infection

Study type

Interventional

Funder types

Other

Identifiers

NCT02774538
2015-A00594-45

Details and patient eligibility

About

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.

Enrollment

165 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

165 participants in 1 patient group

Experimental arm
Other group
Treatment:
Other: Agreement between oral and cervical HPV infection

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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