Nabothian Cyst Protects or Facilitates Against Cervical Cancer

July 24, 2020 updated by: Cihan Comba, Haseki Training and Research Hospital

Naboth Kisti ve HPV pozitifliği arasındaki ilişkinin araştırılması

Aim of the study to asses the realition between HPV infection, Nabothian Cyst and Cervical Intraepithelial lesions or Cervical Cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nabothian cysts are one of the common gynecological pathologies. They rarely have clinical significance. Transvaginal ultrasonography and magnetic resonance imaging are the most useful imaging methods for cervical cystic lesions.HPV infection is the most important factor which can cause cervical malignancy and premalignant lesions. In women between 30-65 years of age HPV-DNA testing, is used as a screening test in Turkey. In this research, the aim is to examine whether there is a connection between Naboth cysts and HPV infection in the cervix. During the examination, the swab sample required for HPV PCR testing will be taken. The number and size of Naboth cysts with vaginal USG will be noted. If the patient had colposcopy / LEEP (Loop Electrosurgical Excision Procedure), the result will be investigated and noted.

Study Type

Observational

Enrollment (Anticipated)

1005

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

the woman; who is between 25-65 years of age, who goes to Haseki Education and Research Hospital Gynecology and Oncology Outpatient Clinic, who has nabothian cyst and/ or HPV infection

Description

Inclusion Criteria:

To have Naboth cyst and/or HPV positivity Must be willing and able to provide informed consent Comply with the study protocol Between 25-65 age range

Exclusion Criteria:

To Refuse participate in our research The age under 25 and over 65 Ovarian, endometrial and vulvar malignancies Without both Naboth's cyst and HPV positivity To have LEEP/Cervical Conization before History of Cervical Dysplasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the woman who has just HPV infection
the woman who is between 30-65 years old, who is participate this research, and has just HPV infection in cervix.
Other: Cervical Cancer Rate
In the end of the Research, we will compare cervical cancer rates between groups
the woman who has just nabothian cyst
the woman who is between 30-65 years old, who is participate this research, and has just nabothian cyst in cervix.
Other: Cervical Cancer Rate
In the end of the Research, we will compare cervical cancer rates between groups
the woman who has both nabothian cyst and HPV infection
the woman who is between 30-65 years old, who is participate this research, and has both nabothian cyst in cervix.
Other: Cervical Cancer Rate
In the end of the Research, we will compare cervical cancer rates between groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nabothian cyst affects the HPV infection in cervix
Time Frame: through study completion, an average of 1 year
in the research, results will be compared for to figure out the relation; nabothian cyst how affects HPV infection , how causes cervical dysplasia in cervix.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does the other factors(like cigarette, birth number, vaginitis) affect HPV infection and Cervical Cancer
Time Frame: through study completion, an average of 1 year
In the research Other factors(like cigarette, birth number, vaginitis) will be also noted. These datas will be used to understand correlation; the other factors increase or decreate the rate of HPV infection and cervical dysplasia.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Investigators

  • Study Chair: Cihan Comba, MD, Sultangazi Haseki Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-74

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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