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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 28, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE June 1, 2015
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
Dysplasia [ Time Frame: 1 month ]
Pathologic diagnosis of cervical dysplasia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology
Official Title  ICMJE Immediate Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Human Papillomavirus Infection
Intervention  ICMJE Other: Colposcopy
Study Arms  ICMJE
  • Experimental: Other High Risk HPV Positivity
    Colposcopy performed to women with High risk HPV positive ,negative for intraepithelial lesions or malignancy cytology
    Intervention: Other: Colposcopy
  • Active Comparator: HPV16/18
    Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology
    Intervention: Other: Colposcopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2020)
185
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2020
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04369339
Other Study ID Numbers  ICMJE OHRHPVCOLP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Serdar Aydın, Bezmialem Vakif University
Study Sponsor  ICMJE Bezmialem Vakif University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bezmialem Vakif University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP