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Trial Title:
Evaluation of the Prevalence of Oral HPV Infection in Patients Who Are Positive to the PAP-test
NCT ID:
NCT05949398
Condition:
HPV Infection
Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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.
Criteria for eligibility:
Study pop:
Women older than 18 years of age who are PAP-test positive.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
AOU Policlinico G. Rodolico
Address:
City:
Catania
Zip:
95124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gaetano Rodolico, DSS
Phone:
+3909537800
Start date:
March 1, 2021
Completion date:
September 26, 2023
Lead sponsor:
Agency:
University of Catania
Agency class:
Other
Source:
University of Catania
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949398
