Nabothian Cyst Protects or Facilitates Against Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Naboth Kisti ve HPV pozitifliği arasındaki ilişkinin araştırılması

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04488991
• Other study ID #: 2020-74
• Status: Recruiting
• Start date: July 23, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2020
• Source: Haseki Training and Research Hospital
• Contact: Cihan Comba, MD
• Phone: 05054735363
• Email: comba.cihan[@]yahoo.com.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1005
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• HPV Infection
• Nabothian Cyst
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

Other:
• Cervical Cancer Rate
In the end of the Research, we will compare cervical cancer rates between groups

Locations

Country	Name	City	State
Turkey	Cihan Comba	Istanbul	Sultangazi

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Barrigón 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 — View Citation

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 — View Citation

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. — View Citation

Malagón 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 May 4. doi: 10.1002/ijc.33035. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nabothian cyst affects the HPV infection in cervix	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	Does the other factors(like cigarette, birth number, vaginitis) affect HPV infection and Cervical Cancer	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