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

NCT05949398 | Unknown

• 1 other identifier: 121-27
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

HPV Infection

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Female patients with negative PAP test
• Uncooperative patients
• Patients with mental deficits
• Age\<18 years

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cytological sampling of oral mucosa cells in order to identify possible genetic material (DNA) of HPV. The tubes with the biological sample to be processed are labeled with the patient's master data. The material should be stored at +4°C or room temperature for no more than 3 weeks.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaetano Isola

  University of Catania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano Isola

CONTACT

0953785652; gaetano.isola@unict.it

Rosalia Leonardi

CONTACT

rleonard@unict.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 18, 2023
• Study Start: March 1, 2021
• Primary Completion: September 13, 2023
• Study Completion: September 26, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

IT (1)