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Trial record 45 of 12460 for:    cervical

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

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ClinicalTrials.gov Identifier: NCT02774538
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

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.


Condition or disease Intervention/treatment Phase
Human Papillomavirus-Related Cervical Carcinoma Other: Agreement between oral and cervical HPV infection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV
Actual Study Start Date : May 11, 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental arm 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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • Patient with HPV cervical infection
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774538


Contacts
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Contact: MERLIN Jean Louis, PharmaD + 33 3 83 59 83 07 jl.merlin@nancy.unicancer.fr
Contact: HUIN SCHOHN Cécile, phD + 33 3 83 59 86 07 c.huinschohn@nancy.unicancer.fr

Locations
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France
Maternité Régionale Universitaire de Nancy Recruiting
Nancy, France, 54000
Contact: Judlin Philippe, Pr       p.judlin@chu-nancy.fr   
Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre-lès-Nancy, France, 54500
Contact: Guillet Julie, Dr       julie.guillet@univ-lorraine.fr   
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: GUILLET Julie, Dr Institut de Cancérologie de Lorraine

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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02774538     History of Changes
Other Study ID Numbers: 2015-A00594-45
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut de Cancérologie de Lorraine:
Cervical HPV infection
Oral HPV infection
Sexually transmitted infection

Additional relevant MeSH terms:
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Infection
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections