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Clinical Trials/NCT03895905
NCT03895905
Completed
Not Applicable

Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity in Normal Women With Cytology

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country409 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Papilloma Virus
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
409
Locations
1
Primary Endpoint
Genotype of HR-HPV 16/18
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The only malignancy screening test among gynecological cancers is cervical cancer.

Cytology examination and Hpv typing with smear are used as screening tests. Hpv positivity is detected in more than 90% of cervical cancers. However, only the Hpv 16-18 type positive patients undergo colposcopy in the routine screening program.

Patients with Smear negative, Type 16-18 high-risk Hpv positivity are evaluated by quota after 1 year.

the authors performed colposcopy with this study; authors aimed to compare the results of patients with type 16-18 Hpv positivity and type 16-18 high-risk Hpv positivity and to find out whether there was any difference between them.

In this way, other high-risk Hpv types other than type 16-18 (31,33,35,45,51, etc.) may be exposed to premalign cervical lesions and possible cancer in a number of earlier and earlier periods by performing colposcopic examination instead of expecting to perform quota after 1 year. we aimed to remove.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
January 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pınar Kadirogulları

principal investigator, M.D, Department of Obstetrics and Gynecology

Kanuni Sultan Suleyman Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • 20-65 years old
  • patients with normal smear

Exclusion Criteria

  • Patients with invasive cervical cancer,
  • HIV-positive patients,
  • ASCUS and more risky premalignant lesions in cytology,
  • Over the age of 65 and
  • Patients under 20 years of age,
  • patients with another known gynecological malignancy

Outcomes

Primary Outcomes

Genotype of HR-HPV 16/18

Time Frame: 1 MONTH

Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV 16/18

Genotype of HR-HPV non 16/18

Time Frame: 1 MONTH

Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV non 16/18

Study Sites (1)

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