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

B

Bezmialem Vakif University

Status

Completed

Conditions

Human Papillomavirus Infection

Treatments

Other: Colposcopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04369339
OHRHPVCOLP

Details and patient eligibility

About

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

Enrollment

185 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

185 participants in 2 patient groups

Other High Risk HPV Positivity
Experimental group
Description:
Colposcopy performed to women with High risk HPV positive ,negative for intraepithelial lesions or malignancy cytology
Treatment:
Other: Colposcopy
HPV16/18
Active Comparator group
Description:
Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology
Treatment:
Other: Colposcopy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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