Human Papilloma VirusNCT03895905
Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity
An observational study of Human Papilloma Virus and Cervical Neoplasm, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The only malignancy screening test among gynecological cancers is cervical cancer. Cytology examination and Hpv typing with smear are used as screening tests. Hpv positivity is detected in more than 90% of cervical cancers. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Human Papilloma Virus, Cervical Neoplasm
- What is being tested?
- colposcopy and colposcopic biopsy
- How many people
- 409 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2016to 1 Jan 2019
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high-risk HPV and colposcopy were the study groups.
Who may be able to join
- 20-65 years old
- patients with normal smear
Who cannot join
- Patients with invasive cervical cancer,
- HIV-positive patients,
- ASCUS and more risky premalignant lesions in cytology,
- Over the age of 65 and
- Patients under 20 years of age,
- patients with another known gynecological malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity in Normal Women With Cytology
The only malignancy screening test among gynecological cancers is cervical cancer.
Cytology examination and Hpv typing with smear are used as screening tests. Hpv positivity is detected in more than 90% of cervical cancers. However, only the Hpv 16-18 type positive patients undergo colposcopy in the routine screening program.
Read more
Patients with Smear negative, Type 16-18 high-risk Hpv positivity are evaluated by quota after 1 year.
the authors performed colposcopy with this study; authors aimed to compare the results of patients with type 16-18 Hpv positivity and type 16-18 high-risk Hpv positivity and to find out whether there was any difference between them.
In this way, other high-risk Hpv types other than type 16-18 (31,33,35,45,51, etc.) may be exposed to premalign cervical lesions and possible cancer in a number of earlier and earlier periods by performing colposcopic examination instead of expecting to perform quota after 1 year. we aimed to remove.
- Conditions
- Human Papilloma Virus, Cervical Neoplasm
- Being tested
- colposcopy and colposcopic biopsy
- Keywords
- colposcopy, High Risk HPV
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colposcopy and colposcopic biopsyDiagnostic test
high-risk hpv positivity and colposcopy and cervical biopsy results will be evaluated. thus, it will be defined whether colposcopy will be performed routinely at high-risk hpv.
| Study group | Role | What they receive |
|---|---|---|
| Genotype of HR-HPV 16/18 | Patients with genotype of HR-HPV 16/18 who underwent cervical biopsy with colposcopy Receives: Diagnostic Test: colposcopy and colposcopic biopsy | |
| Genotype of HR-HPV Non-16/18 | Patients with genotype of HR-HPV non-16/18 who underwent cervical biopsy with colposcopy Receives: Diagnostic Test: colposcopy and colposcopic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype of HR-HPV 16/18
Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV 16/18
Measured: 1 MONTH
Genotype of HR-HPV non 16/18
Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV non 16/18
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Dec 2016
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895905
- Sponsor's protocol ID
- 2018.7.03
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity in Normal Women With Cytology
- ClinicalTrials.gov ID
- NCT03895905
- Acronym / sponsor ID
- 2018.7.03
- Conditions
- Human Papilloma Virus, Cervical Neoplasm
- Keywords
- colposcopy, High Risk HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 29 Mar 2019 (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.
The only malignancy screening test among gynecological cancers is cervical cancer.
Cytology examination and Hpv typing with smear are used as screening tests. Hpv positivity is detected in more than 90% of cervical cancers. However, only the Hpv 16-18 type positive patients undergo colposcopy in the routine screening program.
Patients with Smear negative, Type 16-18 high-risk Hpv positivity are evaluated by quota after 1 year.
the authors performed colposcopy with this study; authors aimed to compare the results of patients with type 16-18 Hpv positivity and type 16-18 high-risk Hpv positivity and to find out whether there was any difference between them.
In this way, other high-risk Hpv types other than type 16-18 (31,33,35,45,51, etc.) may be exposed to premalign cervical lesions and possible cancer in a number of earlier and earlier periods by performing colposcopic examination instead of expecting to perform quota after 1 year. we aimed to remove.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype of HR-HPV 16/18 | – | Diagnostic Test: colposcopy and colposcopic biopsyPatients with genotype of HR-HPV 16/18 who underwent cervical biopsy with colposcopy |
| Genotype of HR-HPV Non-16/18 | – | Diagnostic Test: colposcopy and colposcopic biopsyPatients with genotype of HR-HPV non-16/18 who underwent cervical biopsy with colposcopy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high-risk HPV and colposcopy were the study groups.
Key inclusion criteria (2 listed)
- 20-65 years old
- patients with normal smear
Key exclusion criteria (6 listed)
- Patients with invasive cervical cancer,
- HIV-positive patients,
- ASCUS and more risky premalignant lesions in cytology,
- Over the age of 65 and
- Patients under 20 years of age,
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 |
|---|---|---|
| colposcopy and colposcopic biopsyhigh-risk hpv positivity and colposcopy and cervical biopsy results will be evaluated. thus, it will be defined whether colposcopy will be performed routinely at high-risk hpv. | Diagnostic test | Genotype of HR-HPV 16/18, Genotype of HR-HPV Non-16/18 |
Primary outcome
Genotype of HR-HPV 16/18
Time frame: 1 MONTH
Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV 16/18
Genotype of HR-HPV non 16/18
Time frame: 1 MONTH
Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV non 16/18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Human Papilloma Virus and Cervical Neoplasm, run by Kanuni Sultan Suleyman 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 29 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype of HR-HPV 16/18 (time frame: 1 MONTH). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2019.