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
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
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
NCT ID
NCT04369339
First Posted
April 28, 2020
Last Updated
April 28, 2020
Sponsor
Bezmialem Vakif University
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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