<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488991</url>
  </required_header>
  <id_info>
    <org_study_id>2020-74</org_study_id>
    <nct_id>NCT04488991</nct_id>
  </id_info>
  <brief_title>Nabothian Cyst Protects or Facilitates Against Cervical Cancer</brief_title>
  <official_title>Naboth Kisti ve HPV pozitifliği arasındaki ilişkinin araştırılması</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haseki Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haseki Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study to asses the realition between HPV infection, Nabothian Cyst and Cervical&#xD;
      Intraepithelial lesions or Cervical Cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nabothian cysts are one of the common gynecological pathologies. They rarely have clinical&#xD;
      significance. Transvaginal ultrasonography and magnetic resonance imaging are the most useful&#xD;
      imaging methods for cervical cystic lesions.HPV infection is the most important factor which&#xD;
      can cause cervical malignancy and premalignant lesions. In women between 30-65 years of age&#xD;
      HPV-DNA testing, is used as a screening test in Turkey. In this research, the aim is to&#xD;
      examine whether there is a connection between Naboth cysts and HPV infection in the cervix.&#xD;
      During the examination, the swab sample required for HPV PCR testing will be taken. The&#xD;
      number and size of Naboth cysts with vaginal USG will be noted. If the patient had colposcopy&#xD;
      / LEEP (Loop Electrosurgical Excision Procedure), the result will be investigated and noted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nabothian cyst affects the HPV infection in cervix</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Does the other factors(like cigarette, birth number, vaginitis) affect HPV infection and Cervical Cancer</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1005</enrollment>
  <condition>HPV Infection</condition>
  <condition>Nabothian Cyst</condition>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>the woman who has just HPV infection</arm_group_label>
    <description>the woman who is between 30-65 years old, who is participate this research, and has just HPV infection in cervix.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the woman who has just nabothian cyst</arm_group_label>
    <description>the woman who is between 30-65 years old, who is participate this research, and has just nabothian cyst in cervix.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the woman who has both nabothian cyst and HPV infection</arm_group_label>
    <description>the woman who is between 30-65 years old, who is participate this research, and has both nabothian cyst in cervix.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical Cancer Rate</intervention_name>
    <description>In the end of the Research, we will compare cervical cancer rates between groups</description>
    <arm_group_label>the woman who has both nabothian cyst and HPV infection</arm_group_label>
    <arm_group_label>the woman who has just HPV infection</arm_group_label>
    <arm_group_label>the woman who has just nabothian cyst</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cervical swap samples will be used as Biospecimen to get know whether there is HPV infection&#xD;
      in cervix, and which tipe of HPV infection occurs in patients' cervix&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        the woman; who is between 25-65 years of age, who goes to Haseki Education and Research&#xD;
        Hospital Gynecology and Oncology Outpatient Clinic, who has nabothian cyst and/ or HPV&#xD;
        infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To have Naboth cyst and/or HPV positivity Must be willing and able to provide informed&#xD;
        consent Comply with the study protocol Between 25-65 age range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        To Refuse participate in our research The age under 25 and over 65 Ovarian, endometrial and&#xD;
        vulvar malignancies Without both Naboth's cyst and HPV positivity To have LEEP/Cervical&#xD;
        Conization before History of Cervical Dysplasia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cihan Comba, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sultangazi Haseki Training and Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cihan Comba, MD</last_name>
    <phone>05054735363</phone>
    <email>comba.cihan@yahoo.com.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cihan Comba</name>
      <address>
        <city>Istanbul</city>
        <state>Sultangazi</state>
        <zip>34265</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cihan Comba</last_name>
      <phone>+095054735363</phone>
      <email>comba.cihan@yahoo.com.tr</email>
    </contact>
    <contact_backup>
      <last_name>fatma karababaoğlu</last_name>
      <phone>+095368791179</phone>
      <email>fatma.karababaoglu@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <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>
    <PMID>32363604</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24978344</PMID>
  </reference>
  <results_reference>
    <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>
    <PMID>30353714</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>30878235</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Haseki Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Cihan Comba</investigator_full_name>
    <investigator_title>gynecological oncology specialist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488991
org study id: 2020-74
nct id: NCT04488991
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the study to asses the realition between HPV infection, Nabothian Cyst and Cervical
      Intraepithelial lesions or Cervical Cancer
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.
observational model: Cohort
time perspective: Prospective
measure: Nabothian cyst affects the HPV infection in cervix
time frame: through study completion, an average of 1 year
description: 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.
measure: 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
description: 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.
arm group label: the woman who has just HPV infection
description: the woman who is between 30-65 years old, who is participate this research, and has just HPV infection in cervix.
arm group label: the woman who has just nabothian cyst
description: the woman who is between 30-65 years old, who is participate this research, and has just nabothian cyst in cervix.
arm group label: the woman who has both nabothian cyst and HPV infection
description: the woman who is between 30-65 years old, who is participate this research, and has both nabothian cyst in cervix.
intervention type: Other
intervention name: Cervical Cancer Rate
description: In the end of the Research, we will compare cervical cancer rates between groups
arm group label: the woman who has both nabothian cyst and HPV infection
arm group label: the woman who has just HPV infection
arm group label: the woman who has just nabothian cyst
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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Cihan Comba, MD
role: Study Chair
affiliation: Sultangazi Haseki Training and Research Hospital
last name: Cihan Comba, MD
phone: 05054735363
email: comba.cihan@yahoo.com.tr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
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.
PMID: 32363604
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.
PMID: 24978344
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.
PMID: 30353714
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.
PMID: 30878235
responsible party type: Principal Investigator
investigator affiliation: Haseki Training and Research Hospital
investigator full name: Cihan Comba
investigator title: gynecological oncology specialist
mesh term: Papillomavirus Infections
mesh term: Uterine Cervical Neoplasms
sharing ipd: No