Clinical trial NCT04488991: Nabothian Cyst Protects or Facilitates Against Cervical Cancer
Official title: Naboth Kisti ve HPV pozitifliği arasındaki ilişkinin araştırılması
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV Infection
Nabothian Cyst
Cervical Cancer
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 1005
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nabothian cyst affects the HPV infection in cervix
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Does the other factors(like cigarette, birth number, vaginitis) affect HPV infection and Cervical Cancer
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cihan Comba
state: Sultangazi
Study officials:
affiliation: Sultangazi Haseki Training and Research Hospital
name: Cihan Comba, MD
role: STUDY_CHAIR
References:
citation: 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.
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.
citation: 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.
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: 10.1016/j.ejogrb.2019.02.024. Epub 2019 Mar 2. No abstract available.