Evaluation of the Prevalence of Oral HPV Infection in Patients Who Are Positive to the PAP-test

NCT ID: NCT05949398

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-09-26

Brief Summary

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The present cross-sectional study aims to assess the prevalence and type distribution of oral HPV infection in PAP-test-positive women aged ≥18 years. The means used in the present study will be the use of anamnestic questionnaires and exfoliative cytology tests at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).

Detailed Description

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The present cross-sectional study aims to evaluate the prevalence and distribution of the type of oral HPV infection in PAP-test positive women.

aged ≥18 years. Sociodemographic and anamnestic data will be collected by questionnaire administration. Data collected will be age, marital status, number of sexual partners, HPV vaccination, oral sex, contraceptive use, systemic diseases, smoking, alcohol consumption, etc.. Next, patients will undergo oral cavity inspection and exfoliative cytology testing at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).

Sample taken sent for cytological analysis to determine the presence of viral DNAand possible typing.

Conditions

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HPV Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Female patients with positive PAP test;
* Age ≥ 18 years

Exclusion Criteria

* Female patients with negative PAP test
* Uncooperative patients
* Patients with mental deficits
* Age\<18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

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AOU Policlinico G. Rodolico

Catania, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gaetano Isola

Role: CONTACT

0953785652

Rosalia Leonardi

Role: CONTACT

Facility Contacts

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Gaetano Rodolico, DSS

Role: primary

+3909537800

Other Identifiers

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121-27

Identifier Type: -

Identifier Source: org_study_id

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