Nabothian Cyst Protects or Facilitates Against Cervical Cancer

NCT04488991 | Unknown

• 1 other identifier: 2020-74
• Study Type: observational
• Target: 1,005
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HPV Infection; Nabothian Cyst; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Does the other factors(like cigarette, birth number, vaginitis) affect HPV infection and Cervical Cancer

  through study completion, an average of 1 year

Study Arms (3)

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

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

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

Interventions

Cervical Cancer Rate OTHER

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 has just HPV infection; the woman who has just nabothian cyst

Eligibility Criteria

• Age: 25 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Cihan Comba

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 32363604 BACKGROUND

• 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.

  PMID: 24978344 BACKGROUND

• 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.

  PMID: 30353714 RESULT

• 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.

  PMID: 30878235 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical swap samples will be used as Biospecimen to get know whether there is HPV infection in cervix, and which tipe of HPV infection occurs in patients' cervix

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Cihan Comba, MD

  Sultangazi Haseki Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Cihan Comba, MD

CONTACT

05054735363; comba.cihan@yahoo.com.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: gynecological oncology specialist

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 28, 2020
• Study Start: July 23, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)