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NCT04369339 Clinical Trial

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

Human Papillomavirus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04369339
Other study ID # OHRHPVCOLP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2015
Est. completion date January 1, 2020

Study information
Verified date April 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 185
Est. completion date January 1, 2020
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Colposcopy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bezmialem Vakif University

Outcome
Type Measure Description Time frame Safety issue
Primary Dysplasia Pathologic diagnosis of cervical dysplasia 1 month
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