Colposcopy and Dynamic Spectral Imaging (DSI)

University of Aarhus

Status: Unknown

Conditions: Cervical Dysplasia; Cervical Lesion; Cervical Neoplasm; Cervical Cancer; Cervical Disease; Cervix Cancer

Treatments: Diagnostic Test: Dynamic Spectral Imaging (DYSIS)

Study type: Observational

Funder types: Other

Identifiers

NCT04249856

DSIcolposcopy_DK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Referred for colposcopy due to a cervical smear test of Atypical Squamous Cells of Undetermined Significance (ASCUS), low-grade intraepithelial lesion (LSIL), atypical squamous cells, cannot exclude a high-grade lesion (ASC-H), high-grade intraepithelial lesion (HSIL), Atypical glandular cells (ACG) or carcinoma in situ (CIS)
• Referred for colposcopy due to follow-up of previously diagnosed CIN (If there has been a minimum of 6 months since previous cervical biopsies)

Exclusion criteria

• Cervical biopsies taken within the last 6 months
• Previous cone procedure
• Currently pregnant
• Pregnant within the last 6 months

Trial design

3,000 participants in 1 patient group

Women examined by colposcopy

Description:

Women referred to colposcopy at our facilities who met inclusion criteria

Treatment:

Diagnostic Test: Dynamic Spectral Imaging (DYSIS)