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

NCT ID: NCT03895905

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-01-01

Brief Summary

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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

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Conditions

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Human Papilloma Virus Cervical Neoplasm

Keywords

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colposcopy High Risk HPV

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Genotype of HR-HPV 16/18

Patients with genotype of HR-HPV 16/18 who underwent cervical biopsy with colposcopy

colposcopy and colposcopic biopsy

Intervention Type DIAGNOSTIC_TEST

high-risk hpv positivity and colposcopy and cervical biopsy results will be evaluated. thus, it will be defined whether colposcopy will be performed routinely at high-risk hpv.

Genotype of HR-HPV Non-16/18

Patients with genotype of HR-HPV non-16/18 who underwent cervical biopsy with colposcopy

colposcopy and colposcopic biopsy

Intervention Type DIAGNOSTIC_TEST

high-risk hpv positivity and colposcopy and cervical biopsy results will be evaluated. thus, it will be defined whether colposcopy will be performed routinely at high-risk hpv.

Interventions

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colposcopy and colposcopic biopsy

high-risk hpv positivity and colposcopy and cervical biopsy results will be evaluated. thus, it will be defined whether colposcopy will be performed routinely at high-risk hpv.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pınar Kadirogulları

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018.7.03

Identifier Type: -

Identifier Source: org_study_id