NCT04415840

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 19, 2022

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

June 1, 2020

Last Update Submit

July 17, 2022

Conditions

Uterine Cervical Dysplasia

Keywords

cervical dysplasiacolposcopyLugol's solutionacetic acid

Outcome Measures

Primary Outcomes (1)

  • 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

    1 minute

Secondary Outcomes (4)

  • Sensitivity

    1 minute

  • Specificity

    1 minute

  • PPV

    1 minute

  • NPV

    1 minute

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-pregnant women referred for colposcopy due to cervical abnormalities

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, 44265, Germany

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ziad Hilal, M.D.

    Zydolab - Institute of Cytology and Immune Cytochemistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 4, 2020

Study Start

May 31, 2020

Primary Completion

May 25, 2021

Study Completion

July 1, 2021

Last Updated

July 19, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)