Colposcopy and Dynamic Spectral Imaging (DSI)

Last updated: January 30, 2020
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Pelvic Cancer

Uterine Disorders

Treatment

N/A

Clinical Study ID

NCT04249856
DSIcolposcopy_DK
  • Ages > 18
  • Female

Study Summary

This study evaluates the Dynamic Spectral Imaging (DSI) Colposcope (DySIS) in it's ability to diagnose cervical dysplasia. Half of participants with be examined by the DySIS colposcope, there the other half will be examined by standard colposcopy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Referred for colposcopy due to a cervical smear test of Atypical Squamous Cells ofUndetermined Significance (ASCUS), low-grade intraepithelial lesion (LSIL), atypicalsquamous cells, cannot exclude a high-grade lesion (ASC-H), high-grade intraepitheliallesion (HSIL), Atypical glandular cells (ACG) or carcinoma in situ (CIS)

  • Referred for colposcopy due to follow-up of previously diagnosed CIN (If there hasbeen a minimum of 6 months since previous cervical biopsies)

Exclusion

Exclusion Criteria:

  • Cervical biopsies taken within the last 6 months

  • Previous cone procedure

  • Currently pregnant

  • Pregnant within the last 6 months

Study Design

Total Participants: 3000
Study Start date:
February 01, 2017
Estimated Completion Date:
October 31, 2020

Study Description

Colposcopy has been shown to be a subjective exam, and is dependant on the colposcopists. Sensitivity for colposcopy has been shown to be as low as 50%.

To improve this, different adjunctive technologies have been introduced to add a more objective approach to the colposcopy exam. One of these devices is the DySIS colposcope, which measures the aceto-white reaction that may occur on the cervix uteri after the application of acetic-acid. The device provides the examiner with a colour-coded map indicating areas of interest. Studies have shown promising results indicating that using this device together with the colposcopists own interpretation of the cervix uteri can potentially lead to an increase in the performance of the colposcopy exam.

In Denmark all women referred for colposcopy have 4 biopsies taken, according to the Danish national guidelines.

In our study these 4 biopsies are as following:

  1. The area the colposcopists views as the worst before the DSI-map is seen. Colposcopy-Directed Biopsy (CDB)

  2. The area indicated as the worst by the DSI-map (DSI-directed biopsy)

  3. additional biopsy

  4. additional biopsy All biopsies are placed in separate containers and analysed separately by specialized pathologists.

Connect with a study center

  • Randers Regional Hospital

    Randers, Danmark 8930
    Denmark

    Active - Recruiting

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Private Gynaecology Clinic

    Aarhus, 8000
    Denmark

    Completed

  • Horsens Regional Hospital

    Horsens, 8700
    Denmark

    Active - Recruiting

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