HPV InfectionNCT04488991
Nabothian Cyst Protects or Facilitates Against Cervical Cancer
An observational study of HPV Infection and Nabothian Cyst, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim of the study to asses the realition between HPV infection, Nabothian Cyst and Cervical Intraepithelial lesions or Cervical Cancer Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- HPV Infection, Nabothian Cyst, Cervical Cancer
- What is being tested?
- Cervical Cancer Rate
- How many people
- 1,005 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jul 2020to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cihan Comba
Istanbul, Sultangazi, 34265
Cihan Comba, +095054735363, comba.cihan@yahoo.com.tr
fatma karababaoğlu, +095368791179, fatma.karababaoglu@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- HPV Infection, Nabothian Cyst, Cervical Cancer
- Being tested
- Cervical Cancer Rate
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Cancer RateOther
In the end of the Research, we will compare cervical cancer rates between groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Cervical Cancer Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start23 Jul 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,005 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihan Comba, Haseki Training and Research Hospital
- Investigators
- Cihan Comba, MD, Study chair, Sultangazi Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488991
- Sponsor's protocol ID
- 2020-74
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32363604Isoda 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.
PubMed 24978344Barrigon 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.
PubMed 30353714D'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.
PubMed 30878235
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naboth Kisti ve HPV pozitifliği arasındaki ilişkinin araştırılması
- ClinicalTrials.gov ID
- NCT04488991
- Acronym / sponsor ID
- 2020-74
- Conditions
- HPV Infection, Nabothian Cyst, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,005 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the woman who has just HPV infection | – | Other: Cervical Cancer Ratethe woman who is between 30-65 years old, who is participate this research, and has just HPV infection in cervix. |
| the woman who has just nabothian cyst | – | Other: Cervical Cancer Ratethe woman who is between 30-65 years old, who is participate this research, and has just nabothian cyst in cervix. |
| the woman who has both nabothian cyst and HPV infection | – | Other: Cervical Cancer Ratethe woman who is between 30-65 years old, who is participate this research, and has both nabothian cyst in cervix. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Cancer RateIn the end of the Research, we will compare cervical cancer rates between groups | Other | the woman who has both nabothian cyst and HPV infection, the woman who has just HPV infection, the woman who has just nabothian cyst |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 32363604Malagon 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.
- Background: PubMed 24978344Isoda 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.
- Results publication: PubMed 30353714Barrigon 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.
- Results publication: PubMed 30878235D'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cihan Comba, MD study chair
Sultangazi Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection and Nabothian Cyst, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cihan Comba, MD (05054735363, comba.cihan@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nabothian cyst affects the HPV infection in cervix (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488991, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.