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

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).

Study Overview

• Status: Recruiting
• Conditions: HPV Infection

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Rosalia Leonardi; Email: rleonard@unict.it
• Study Contact Backup: Name: Gaetano Isola; Phone Number: 0953785652; Email: gaetano.isola@unict.it

Study Locations

• Italy
  • Catania, Italy, 95124
    • Recruiting
    • AOU Policlinico G. Rodolico
    • Contact: Gaetano Rodolico, DSS; Phone Number: +3909537800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women older than 18 years of age who are PAP-test positive.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence and type of oral HPV infection in PAP-test positive patients	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.	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,	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.	1 Month

Collaborators and Investigators

• Sponsor: University of Catania
• Investigators: Principal Investigator: Gaetano Isola, University of Catania

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): September 13, 2023
• Study Completion (Estimated): September 26, 2023

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Papillomavirus Infections
• Other Study ID Numbers: 121-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No