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

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ClinicalTrials.gov Identifier: NCT04369339
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Serdar Aydın, Bezmialem Vakif University

Brief 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

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Other: Colposcopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective cohort study comparing the immediate colposcopy findings among women with HrHPV other than HVPV16/18 and negative cytology
Masking: Single (Outcomes Assessor)
Masking Description: outcomes assessor blind to clinical data and cytology results
Primary Purpose: Diagnostic
Official Title: Immediate Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : January 1, 2020

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



Primary Outcome Measures :
  1. Dysplasia [ Time Frame: 1 month ]
    Pathologic diagnosis of cervical dysplasia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Serdar Aydın, Assoc. Prof., Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04369339    
Other Study ID Numbers: OHRHPVCOLP
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Serdar Aydın, Bezmialem Vakif University:
Human Papilloma Virus
negative for intraepithelial lesions or malignancy
HPV16
HPV18
Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections