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Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology

NCT ID: NCT04369339

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2020-01-01

Brief Summary

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Abnormal cervical cytology was the most common reason for women being referred to the colposcopy unit. We prospectively included the women with negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive High RiskHPV test other than HPV 16 or HPV 18. Comparing the immediate colposcopy findings among women with High Risk HPV other than HVPV16/18 and negative cytology and determine positive predictive values for CIN2+ of other high risk HPV genotypes

Detailed Description

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Conditions

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Human Papillomavirus Infection

Keywords

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Human Papilloma Virus negative for intraepithelial lesions or malignancy HPV16 HPV18

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective cohort study comparing the immediate colposcopy findings among women with HrHPV other than HVPV16/18 and negative cytology
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
outcomes assessor blind to clinical data and cytology results

Study Groups

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Other High Risk HPV Positivity

Colposcopy performed to women with High risk HPV positive ,negative for intraepithelial lesions or malignancy cytology

Group Type EXPERIMENTAL

Colposcopy

Intervention Type OTHER

HPV16/18

Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology

Group Type ACTIVE_COMPARATOR

Colposcopy

Intervention Type OTHER

Interventions

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Colposcopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive HrHPV test other than HPV 16 or HPV 18

Exclusion Criteria

* Previous diagnosis for cervical cancer Previous diagnosis for vaginal cancer Previous diagnosis for cervical dysplasia Previous diagnosis for ASCUS previous history of cervical conisation or hysterectomy previous history ofhysterectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Serdar Aydın

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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OHRHPVCOLP

Identifier Type: -

Identifier Source: org_study_id