JOURNAL ONKOLOGIE – STUDIE
Lugol's Solution in Addition to Acetic Acid During Colposcopy
Rekrutierend
NCT-Nummer:
NCT04415840
Studienbeginn:
Mai 2020
Letztes Update:
04.06.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Uterine Cervical Dysplasia, Cervical Intraepithelial Neoplasia
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Zydolab - Institute of Cytology and Immune Cytochemistry
Collaborator:
-
Studienleiter
Principal Investigator
Zydolab - Institute of Cytology and Immune Cytochemistry
Kontakt
Kontakt:
Phone: +0049 231 579349
E-Mail: z.hilal@zydolab.de» Kontaktdaten anzeigen
Kontakt:
Phone: +0049 2323 499 1801
E-Mail: clemens.tempfer@rub.de» Kontaktdaten anzeigen
Studienlocations (2 von 2)
Zydolab - Institute of Cytology and Immune Cytochemistry
44137 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ziad Hilal, M.D.
Phone: +0049 231 579349
E-Mail: z.hilal@zydolab.de» Ansprechpartner anzeigenDepartment of Obstetrics and Gynecology of the Ruhr University Bochum
44265 Herne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Clemens B. Tempfer, M.D., MBA
Phone: 02323 499 1801
E-Mail: Clemens.Tempfer@rub.de» Ansprechpartner anzeigen
44137 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ziad Hilal, M.D.
Phone: +0049 231 579349
E-Mail: z.hilal@zydolab.de» Ansprechpartner anzeigenDepartment of Obstetrics and Gynecology of the Ruhr University Bochum
44265 Herne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Clemens B. Tempfer, M.D., MBA
Phone: 02323 499 1801
E-Mail: Clemens.Tempfer@rub.de» Ansprechpartner anzeigen
Studien-Informationen
Brief Summary:To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome: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:
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)
Geprüfte Regime
- acetic acid test:
using acetic acid to unmask dysplastic lesions on the cervix uteri - Lugol's solution test:
using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri
Quelle: ClinicalTrials.gov