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

HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949398
• Other study ID #: 121-27
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: July 2023
• Source: University of Catania
• Contact: Gaetano Isola
• Phone: 0953785652
• Email: gaetano.isola[@]unict.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 26, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HPV Infection
• Infections
• Papillomavirus Infections

Locations

Country	Name	City	State
Italy	AOU Policlinico G. Rodolico	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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