Oral and Anal Swab Sampling in Patients With HPV Positivity | NCT06906913

Studies
Oral and Anal Swab Sampling in Patients With HPV Positivity

NCT06906913

Sponsor

Medipol University

Status

Completed

Last Update Posted

Apr 2, 2025Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Interventions

HPV testing

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TF.HZP.23.31	Other Grant/Funding Number	Gaziantep University Scientific Research Project support program

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2023Actual

Primary Completion Date

Jul 31, 2024Actual

Completion Date

Nov 19, 2024Actual

First Submitted Date

Mar 26, 2025

First Submission Date that Met QC Criteria

Mar 26, 2025

First Posted Date

Apr 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Apr 2, 2025Actual

Name	Class
gaziantep university medicine faculty	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Swab Sampling		Oropharyngeal and anal swab samples are obtained.	Diagnostic Test: HPV testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HPV testing	Diagnostic Test	Oropharyngeal and anal swab samples are evaluated in the Microbiology laboratory for the existence of HPV.	Swab Sampling

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neslihan Bayramoglu Tepe, Doctor of Medicine	University of Gaziantep	Study Director
Ozan Dogan, Prof. Dr.	Istanbul Nisantasi University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziantep Cengiz Gokcek Women's, Obstetrics and Pediatrics Hospital		Gaziantep	Gaziantep	27010	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided