Oral and Anal Swab Sampling in Patients With HPV Positivity (Oral Anal HPV)

March 26, 2025 updated by: Tugba Akcaoglu, Medipol University

Evaluation of Oropharyngeal and Anal Swab Samples in Patients With HPV Positivity

Patients whose pathology results are reported as cervical intraepithelial neoplasia (CIN) 1, CIN 2, and CIN 3, are recruited. We aimed to evaluate HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3, by collecting oropharyngeal and anal swab samples. A total of 30 women of reproductive age, who consented to participate, were included in the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Human papillomavirus (HPV) positivity is associated with cervical, oropharyngeal, and anal cancers. There is insufficient data in the current literature regarding the effectiveness of obtaining oropharyngeal and anal swabs from patients with HPV positivity is an effective method for detecting potential pathologies. HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3, will be evaluated by collecting oropharyngeal and anal swab samples.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gaziantep, Turkey, 27010
        • Gaziantep Cengiz Gokcek Women's, Obstetrics and Pediatrics Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A total of 30 women of reproductive age, who consented to participate, will be included in the study.

Description

Inclusion Criteria:

  • HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3

Exclusion Criteria:

  • HPV-negative women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Swab Sampling
Oropharyngeal and anal swab samples are obtained.
Oropharyngeal and anal swab samples are evaluated in the Microbiology laboratory for the existence of HPV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal Swab Sample - HPV Testing
Time Frame: 1 month
Presence of HPV will be tested
1 month
Anal Swab Sample - HPV Testing
Time Frame: 1 month
Presence of HPV
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal Swab Sample - HPV Testing (if positive)
Time Frame: 1 month
Type of HPV
1 month
Anal Swab Sample - HPV Testing (if positive)
Time Frame: 1 month
Type of HPV
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Neslihan Bayramoglu Tepe, Doctor of Medicine, University of Gaziantep
  • Study Chair: Ozan Dogan, Prof. Dr., Istanbul Nisantasi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

November 19, 2024

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Number 362
  • TF.HZP.23.31 (Other Grant/Funding Number: Gaziantep University Scientific Research Project support program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The study results can be kept confidential before being published in a journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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