Cervical DysplasiaNCT03840187
Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System
An observational study of Cervical Dysplasia, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
Correlation between colposcopist findings and digital cervicography employing Gynescope system Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- Digital cervicography
- How many people
- 29 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Mar 2019to 15 Jan 2020
- 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 18 to 65 years
- Women only
- Adult, Older adult
Study population: Patients reffered for colposcopy
Who may be able to join
- Patients reffered for colposcopy
Who cannot join
- Patient refusion
Trial locations and contacts
1 site in 1 country.
About this study
Correlation between colposcopist findings and digital cervicography employing Gynescope system
Read the detailed description
Up to 30 women that will be referred for colposcopy examination at the standard indications will also undergo a colposcopy examination of the cervix by a gynescope. The physicain performing the optical test will record the findings in accordance with the International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Categorical variable will be included in every record. At later stage, the images obtained by the cervicography will be evaluated and recorded in accordance with the IFCPC terminology. Correlation between the categorical findings in both assesments will be compared. The correlation measure will be performed by Kappa test according to the categorial result of both measurements.
- Conditions
- Cervical Dysplasia
- Being tested
- Digital cervicography
- Keywords
- digital cervicography, Gynescope system
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital cervicographyDiagnostic test
Colposcopist findings and digital cervicography employing Gynescope system
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy
leukoplakia, aceto - white change, mosaic, punctuation, and abnormal vessels
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start11 Mar 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DysplasiaStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ofer Gemer, Professor, Principal investigator, Barzilai University Medical Center Ashkelon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840187
- Sponsor's protocol ID
- 0097-18-BRZ
- Status last verified
- Jan 2019
- First submitted
- 4 Feb 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System
- ClinicalTrials.gov ID
- NCT03840187
- Acronym / sponsor ID
- 0097-18-BRZ
- Conditions
- Cervical Dysplasia
- Keywords
- digital cervicography, Gynescope system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 15 Feb 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.
Correlation between colposcopist findings and digital cervicography employing Gynescope system
Detailed description
Up to 30 women that will be referred for colposcopy examination at the standard indications will also undergo a colposcopy examination of the cervix by a gynescope. The physicain performing the optical test will record the findings in accordance with the International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Categorical variable will be included in every record. At later stage, the images obtained by the cervicography will be evaluated and recorded in accordance with the IFCPC terminology. Correlation between the categorical findings in both assesments will be compared. The correlation measure will be performed by Kappa test according to the categorial result of both measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients reffered for colposcopy
Key inclusion criteria (1 listed)
- Patients reffered for colposcopy
Key exclusion criteria (1 listed)
- Patient refusion
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 |
|---|---|---|
| Digital cervicographyColposcopist findings and digital cervicography employing Gynescope system | Diagnostic test | – |
Primary outcome
Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy
Time frame: 5 months
leukoplakia, aceto - white change, mosaic, punctuation, and abnormal vessels
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 18 Jan 2020.
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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.
Ofer Gemer, Professor principal investigator
Barzilai University Medical Center Ashkelon
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 Cervical Dysplasia, run by Barzilai Medical Center at 1 site in Israel.
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: finished, as of the sponsor's last update on 18 Jan 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 Israel. 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?
Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy (time frame: 5 months). 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 18 Jan 2020.