Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity

Completed

• Conditions: Cervical Neoplasm; Human Papilloma Virus
• Interventions: Diagnostic Test: colposcopy and colposcopic biopsy

• Registration Number: NCT03895905
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Study First Posted: 2019-03-29
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 409

Inclusion Criteria

• 20-65 years old
• patients with normal smear

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Genotype of HR-HPV Non-16/18	colposcopy and colposcopic biopsy	Patients with genotype of HR-HPV non-16/18 who underwent cervical biopsy with colposcopy
Genotype of HR-HPV 16/18	colposcopy and colposcopic biopsy	Patients with genotype of HR-HPV 16/18 who underwent cervical biopsy with colposcopy

Primary Outcome Measures

Name	Time	Method
Genotype of HR-HPV 16/18	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	1 MONTH	Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV non 16/18

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey