HPV InfectionNCT05949398
Evaluation of the Prevalence of Oral HPV Infection in Patients Who Are Positive to the PAP-test
An observational study of HPV Infection, run by University of Catania at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 26 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women older than 18 years of age who are PAP-test positive.
Who may be able to join
- Female patients with positive PAP test;
- Age ≥ 18 years
Who cannot join
- Female patients with negative PAP test
- Uncooperative patients
- Patients with mental deficits
- Age<18 years
Trial locations and contacts
1 site in 1 country.
Rosalia Leonardi contact
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico G. Rodolico
Catania, 95124
Gaetano Rodolico, DSS, +3909537800
About this study
Official title: 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).
Read the 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.
- Conditions
- HPV Infection
- Medical subject headings
- Papillomavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Mar 2021
- Primary completion13 Sep 2023 (estimated)
- Study completion26 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949398
- Sponsor's protocol ID
- 121-27
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence and Type of Oral HPV Infection in Patients Who Are Positive to the PAP-test
- ClinicalTrials.gov ID
- NCT05949398
- Acronym / sponsor ID
- 121-27
- Conditions
- HPV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 13 Sep 2023 (estimated)
- Study completion
- 26 Sep 2023 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women older than 18 years of age who are PAP-test positive.
Key inclusion criteria (2 listed)
- Female patients with positive PAP test;
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Female patients with negative PAP test
- Uncooperative patients
- Patients with mental deficits
- Age<18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and type of oral HPV infection in PAP-test positive patients
Time frame: 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,
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalia Leonardi contact
Gaetano Isola principal investigator
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Isola (0953785652, gaetano.isola@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and type of oral HPV infection in PAP-test positive patients (time frame: 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.