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Lugol's Solution in Addition to Acetic Acid During Colposcopy

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ClinicalTrials.gov Identifier: NCT04415840
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Zydolab - Institute of Cytology and Immune Cytochemistry

Brief Summary:
To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.

Condition or disease Intervention/treatment
Uterine Cervical Dysplasia Diagnostic Test: acetic acid test Diagnostic Test: Lugol's solution test

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia
Actual Study Start Date : May 31, 2020
Estimated Primary Completion Date : March 25, 2023
Estimated Study Completion Date : April 1, 2023



Intervention Details:
  • Diagnostic Test: acetic acid test
    using acetic acid to unmask dysplastic lesions on the cervix uteri
  • Diagnostic Test: Lugol's solution test
    using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sensitivity [ Time Frame: 1 minute ]
    sensitivity of the examination (acetic acid + Lugol´s solution)

  2. Specificity [ Time Frame: 1 minute ]
    Specificity of the examination (acetic acid + Lugol´s solution)

  3. PPV [ Time Frame: 1 minute ]
    Positive predictive value of the examination (acetic acid + Lugol´s solution)

  4. NPV [ Time Frame: 1 minute ]
    Negative predictive value of the examination (acetic acid + Lugol´s solution)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Non-pregnant women referred for colposcopy due to cervical abnormalities
Criteria

Inclusion Criteria:

  • women referred for colposcopy due to cervical abnormalities
  • written informed consent

Exclusion Criteria:

  • pregnant women
  • presence of a language barrier
  • history of conization or other treatments on the cervix uteri
  • iodine allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415840


Contacts
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Contact: Ziad Hilal, M.D. +0049 231 579349 z.hilal@zydolab.de
Contact: Clemens B. Tempfer, M.D., MBA +0049 2323 499 1801 clemens.tempfer@rub.de

Locations
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Germany
Zydolab - Institute of Cytology and Immune Cytochemistry Recruiting
Dortmund, NRW, Germany, 44137
Contact: Ziad Hilal, M.D.    +0049 231 579349    z.hilal@zydolab.de   
Department of Obstetrics and Gynecology of the Ruhr University Bochum Recruiting
Herne, NRW, Germany, 44265
Contact: Clemens B. Tempfer, M.D., MBA    02323 499 1801    Clemens.Tempfer@rub.de   
Sponsors and Collaborators
Zydolab - Institute of Cytology and Immune Cytochemistry
Investigators
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Principal Investigator: Ziad Hilal, M.D. Zydolab - Institute of Cytology and Immune Cytochemistry
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Responsible Party: Zydolab - Institute of Cytology and Immune Cytochemistry
ClinicalTrials.gov Identifier: NCT04415840    
Other Study ID Numbers: COLPO-4
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zydolab - Institute of Cytology and Immune Cytochemistry:
cervical dysplasia
colposcopy
Lugol's solution
acetic acid
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Acetic Acid
Retinol acetate
Lugol's solution
Anti-Bacterial Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Hemostatics
Coagulants