NCT06906913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

March 26, 2025

Last Update Submit

March 26, 2025

Conditions

HPV

Keywords

Analcervicalhuman papillomavirusoropharyngealscreening

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Oropharyngeal Swab Sample - HPV Testing (if positive)

    1 month

  • Anal Swab Sample - HPV Testing (if positive)

    1 month

Study Arms (1)

Swab Sampling

Oropharyngeal and anal swab samples are obtained.

Diagnostic Test: HPV testing

Interventions

HPV testingDIAGNOSTIC_TEST

Oropharyngeal and anal swab samples are evaluated in the Microbiology laboratory for the existence of HPV.

Swab Sampling

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • HPV-negative women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Cengiz Gokcek Women's, Obstetrics and Pediatrics Hospital

Gaziantep, Gaziantep, 27010, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oropharyngeal and anal swab samples will be obtained.

Study Officials

  • Neslihan Bayramoglu Tepe, Doctor of Medicine

    University of Gaziantep

    STUDY DIRECTOR

  • Ozan Dogan, Prof. Dr.

    Istanbul Nisantasi University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 2, 2025

Study Start

March 14, 2023

Primary Completion

July 31, 2024

Study Completion

November 19, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations

TU(1)