HPVOral Anal HPVNCT06906913
Oral and Anal Swab Sampling in Patients With HPV Positivity
An observational study of HPV, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- HPV
- What is being tested?
- HPV testing
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2023to 19 Nov 2024
- How long will I take part?
- 1 Month
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: A total of 30 women of reproductive age, who consented to participate, will be included in the study.
Who may be able to join
- HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3
Who cannot join
- HPV-negative women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Cengiz Gokcek Women's, Obstetrics and Pediatrics Hospital
Gaziantep, Gaziantep, 27010
About this study
Official title: 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.
Read the 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.
- Conditions
- HPV
- Being tested
- HPV testing
- Keywords
- Anal, cervical, human papillomavirus, oropharyngeal, screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV testingDiagnostic test
Oropharyngeal and anal swab samples are evaluated in the Microbiology laboratory for the existence of HPV.
| Study group | Role | What they receive |
|---|---|---|
| Swab Sampling | Oropharyngeal and anal swab samples are obtained. Receives: Diagnostic Test: HPV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal Swab Sample - HPV Testing
Presence of HPV will be tested
Measured: 1 month
Anal Swab Sample - HPV Testing
Presence of HPV
Measured: 1 month
Secondary outcomes (2)
Oropharyngeal Swab Sample - HPV Testing (if positive)
Type of HPV
Measured: 1 month
Anal Swab Sample - HPV Testing (if positive)
Type of HPV
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 posted2 Apr 2025
- Study start14 Mar 2023
- Primary completion31 Jul 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- gaziantep university medicine faculty
- Responsible party
- Principal investigator, Tugba Akcaoglu, Medipol University
- Investigators
- Neslihan Bayramoglu Tepe, Doctor of Medicine, Study director, University of GaziantepOzan Dogan, Prof. Dr., Study chair, Istanbul Nisantasi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906913
- Sponsor's protocol ID
- Number 362
- Other IDs
- TF.HZP.23.31
- Acronym
- Oral Anal HPV
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study results can be kept confidential before being published in a journal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oropharyngeal and Anal Swab Samples in Patients With HPV Positivity
- ClinicalTrials.gov ID
- NCT06906913
- Acronym / sponsor ID
- Oral Anal HPV / Number 362
- Conditions
- HPV
- Keywords
- Anal, cervical, human papillomavirus, oropharyngeal, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- gaziantep university medicine faculty
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 2 Apr 2025 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swab Sampling | – | Diagnostic Test: HPV testingOropharyngeal and anal swab samples are obtained. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of 30 women of reproductive age, who consented to participate, will be included in the study.
Key inclusion criteria (1 listed)
- HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3
Key exclusion criteria (1 listed)
- HPV-negative women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV testingOropharyngeal and anal swab samples are evaluated in the Microbiology laboratory for the existence of HPV. | Diagnostic test | Swab Sampling |
Primary outcome
Oropharyngeal Swab Sample - HPV Testing
Time frame: 1 month
Presence of HPV will be tested
Anal Swab Sample - HPV Testing
Time frame: 1 month
Presence of HPV
2 secondary outcomes
Oropharyngeal Swab Sample - HPV Testing (if positive)
Time frame: 1 month
Anal Swab Sample - HPV Testing (if positive)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided. The study results can be kept confidential before being published in a journal.
Related trials for HPV
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Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
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RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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.
Neslihan Bayramoglu Tepe, Doctor of Medicine study director
University of Gaziantep
Ozan Dogan, Prof. Dr. study chair
Istanbul Nisantasi University
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, run by Medipol University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Apr 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal Swab Sample - HPV Testing (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 2 Apr 2025.