- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06906913
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
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
-
-
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Gaziantep, Turkey, 27010
- Gaziantep Cengiz Gokcek Women's, Obstetrics and Pediatrics Hospital
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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.
Sponsor
Collaborators
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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