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

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.

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Key information

Conditions

Human Papilloma Virus Cervical Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colposcopy and colposcopic biopsy

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.

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

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2019
First posted: Mar 29, 2019
Registry last updated: Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed