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

Primary Purpose

Human Papillomavirus Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Colposcopy
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Human Papillomavirus Infection focused on measuring Human Papilloma Virus, negative for intraepithelial lesions or malignancy, HPV16, HPV18

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Other High Risk HPV Positivity

    HPV16/18

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Dysplasia
    Pathologic diagnosis of cervical dysplasia

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2020
    Last Updated
    April 28, 2020
    Sponsor
    Bezmialem Vakif University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04369339
    Brief Title
    Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology
    Official Title
    Immediate Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    October 1, 2019 (Actual)
    Study Completion Date
    January 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bezmialem Vakif University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Papillomavirus Infection
    Keywords
    Human Papilloma Virus, negative for intraepithelial lesions or malignancy, HPV16, HPV18

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective cohort study comparing the immediate colposcopy findings among women with HrHPV other than HVPV16/18 and negative cytology
    Masking
    Outcomes Assessor
    Masking Description
    outcomes assessor blind to clinical data and cytology results
    Allocation
    Non-Randomized
    Enrollment
    185 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Other High Risk HPV Positivity
    Arm Type
    Experimental
    Arm Description
    Colposcopy performed to women with High risk HPV positive ,negative for intraepithelial lesions or malignancy cytology
    Arm Title
    HPV16/18
    Arm Type
    Active Comparator
    Arm Description
    Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology
    Intervention Type
    Other
    Intervention Name(s)
    Colposcopy
    Primary Outcome Measure Information:
    Title
    Dysplasia
    Description
    Pathologic diagnosis of cervical dysplasia
    Time Frame
    1 month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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