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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05949398

Enrollment

Registered

2023-07-18

Start date

2021-03-01

Completion date

2023-09-26

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Infection

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence and type of oral HPV infection in PAP-test positive patients	1 Month	Evaluation of the prevalence and type of oral HPV infection in PAP-test positive patients by objective examination of the oral cavity and performance of exfoliative cytology tests at oral mucosal sites predetermined (lingual belly and dorsum, palate, and buccal mucosa). The data will then be processed through the appropriate statistical examinations.
To assess whether there are any factors that may or may not promote the occurrence of oral HPV lesions in PAP-test positive patients,	1 Month	To assess whether there are any factors that may or may not promote the occurrence of oral HPV lesions in PAP-test positive patients, such as sociodemographic characteristics, diabetes, smoking, alcohol, HPV vaccination, etc. The data collected are as follows: * Collection of sociodemographic data by questionnaires (age, gender, civil status, education level, and occupation); * Collection of medical history data by questionnaires (smoking, alcohol consumption, diabetes or/and other systemic diseases, number of sexual partners, age of first intercourse, contraceptive use, type of contraceptive, HPV vaccination, sexual partners with genital/oral HPV infection). the following collected data will then be processed by statistical association surveys and uni and multivariate regression analyses.

Countries

Italy

Contacts

Primary ContactGaetano Isola

gaetano.isola@unict.it0953785652

Backup ContactRosalia Leonardi

rleonard@unict.it

Outcome results