Uterine Cervical DysplasiaNCT04415840
Lugol's Solution in Addition to Acetic Acid During Colposcopy
An observational study of Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 2 sites in Germany.
Trial summary
To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Uterine Cervical Dysplasia
- What is being tested?
- acetic acid test and Lugol's solution test
- How many people
- 323 participants
- Where
- 2 sitesGermany
- Study dates
- 31 May 2020to 1 Jul 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 18 to 80 years
- Women only
- Adult, Older adult
Study population: Non-pregnant women referred for colposcopy due to cervical abnormalities
Who may be able to join
- women referred for colposcopy due to cervical abnormalities
- written informed consent
Who cannot join
- pregnant women
- presence of a language barrier
- history of conization or other treatments on the cervix uteri
- iodine allergy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Zydolab - Institute of Cytology and Immune Cytochemistry
Dortmund, North Rhine-Westphalia, 44137
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44265
About this study
Official title: Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia
To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- acetic acid test, Lugol's solution test
- Keywords
- cervical dysplasia, colposcopy, Lugol's solution, acetic acid
- 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.
acetic acid testDiagnostic test
using acetic acid to unmask dysplastic lesions on the cervix uteri
Lugol's solution testDiagnostic test
using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri
What is being measured
The primary outcome is the main question the study is designed to answer.
additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution
We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use
Measured: 1 minute
Secondary outcomes (4)
Sensitivity
sensitivity of the examination (acetic acid + Lugol´s solution)
Measured: 1 minute
Specificity
Specificity of the examination (acetic acid + Lugol´s solution)
Measured: 1 minute
PPV
Positive predictive value of the examination (acetic acid + Lugol´s solution)
Measured: 1 minute
NPV
Negative predictive value of the examination (acetic acid + Lugol´s solution)
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start31 May 2020
- Primary completion25 May 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine 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
- Other
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydolab - Institute of Cytology and Immune Cytochemistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziad Hilal, M.D., Principal investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415840
- Sponsor's protocol ID
- COLPO-4
- Status last verified
- Apr 2021
- First submitted
- 1 Jun 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia
- ClinicalTrials.gov ID
- NCT04415840
- Acronym / sponsor ID
- COLPO-4
- Conditions
- Uterine Cervical Dysplasia
- Keywords
- cervical dysplasia, colposcopy, Lugol's solution, acetic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Zydolab - Institute of Cytology and Immune CytochemistryUniversity, hospital or other
- Study start
- 31 May 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 4 Jun 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.
To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Non-pregnant women referred for colposcopy due to cervical abnormalities
Key inclusion criteria (2 listed)
- women referred for colposcopy due to cervical abnormalities
- written informed consent
Key exclusion criteria (4 listed)
- pregnant women
- presence of a language barrier
- history of conization or other treatments on the cervix uteri
- iodine allergy
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 |
|---|---|---|
| acetic acid testusing acetic acid to unmask dysplastic lesions on the cervix uteri | Diagnostic test | – |
| Lugol's solution testusing Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri | Diagnostic test | – |
Primary outcome
additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution
Time frame: 1 minute
We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use
4 secondary outcomes
Sensitivity
Time frame: 1 minute
Specificity
Time frame: 1 minute
PPV
Time frame: 1 minute
NPV
Time frame: 1 minute
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 19 Jul 2022.
- 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.
Ziad Hilal, M.D. principal investigator
Zydolab - Institute of Cytology and Immune Cytochemistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 2 sites in Germany.
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 4 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution (time frame: 1 minute). 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 19 Jul 2022.