- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04488991
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
- Name: Cihan Comba, MD
- Phone Number: 05054735363
- Email: comba.cihan@yahoo.com.tr
Study Locations
-
-
Sultangazi
-
Istanbul, Sultangazi, Turkey, 34265
- Recruiting
- Cihan Comba
-
Contact:
- Cihan Comba
- Phone Number: +095054735363
- Email: comba.cihan@yahoo.com.tr
-
Contact:
- fatma karababaoğlu
- Phone Number: +095368791179
- Email: fatma.karababaoglu@gmail.com
-
-
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.
|
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.
|
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.
|
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.
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
- Malagon T, Volesky KD, Bouten S, Laprise C, El-Zein M, Franco EL. Cumulative risk of cervical intraepithelial neoplasia for women with normal cytology but positive for human papillomavirus: Systematic review and meta-analysis. Int J Cancer. 2020 Nov 15;147(10):2695-2707. doi: 10.1002/ijc.33035. Epub 2020 May 26.
- Isoda T, BaBa S, Maruoka Y, Kitamura Y, Nishie A, Sasaki M, Honda H. Nabothian cyst a predominant cause of false-positive iodine uptake in uterus: comparison of SPECT/CT and pelvic MRI. Clin Nucl Med. 2014 Aug;39(8):680-4. doi: 10.1097/RLU.0000000000000504.
- Barrigon A, Ziadi S, Jacot-Guillarmod M, Da Silva S, Dumont M, Raineri I, Bongiovanni M. Nabothian cyst content: A potential pitfall for the diagnosis of invasive cancer on Pap test cytology. Diagn Cytopathol. 2019 Feb;47(2):127-129. doi: 10.1002/dc.24098. Epub 2018 Oct 24.
- D'Alessandro P, Giudicepietro A, Della Corte L, Arduino B, Saccone G, Iacobelli A, Insabato L, Zullo F. A case of gastric-type mucinous endocervical adenocarcinoma in presence of nabothian cysts. Eur J Obstet Gynecol Reprod Biol. 2019 May;236:254-255. doi: 10.1016/j.ejogrb.2019.02.024. Epub 2019 Mar 2. No abstract available.
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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