Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity
1 other identifier
observational
409
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedMarch 29, 2019
March 1, 2019
2 years
March 26, 2019
March 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Genotype of HR-HPV 16/18
Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV 16/18
1 MONTH
Genotype of HR-HPV non 16/18
Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV non 16/18
1 MONTH
Study Arms (2)
Genotype of HR-HPV 16/18
Patients with genotype of HR-HPV 16/18 who underwent cervical biopsy with colposcopy
Genotype of HR-HPV Non-16/18
Patients with genotype of HR-HPV non-16/18 who underwent cervical biopsy with colposcopy
Interventions
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.
Eligibility Criteria
Patients with high-risk HPV and colposcopy were the study groups.
You may qualify if:
- years old
- patients with normal smear
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator, M.D, Department of Obstetrics and Gynecology
Study Record Dates
First Submitted
March 26, 2019
First Posted
March 29, 2019
Study Start
December 1, 2016
Primary Completion
December 1, 2018
Study Completion
January 1, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03