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
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Sponsor:
Bezmialem Vakif University
Information provided by (Responsible Party):
Serdar Aydın, Bezmialem Vakif University
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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 |
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
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Other: Colposcopy |
Active Comparator: HPV16/18
Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology
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Other: Colposcopy |
Primary Outcome Measures :
- Dysplasia [ Time Frame: 1 month ]Pathologic diagnosis of cervical dysplasia
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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
No Contacts or Locations Provided
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 |
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:
Papillomavirus Infections DNA Virus Infections Virus Diseases Tumor Virus Infections |