Colposcopy and Dynamic Spectral Imaging (DSI)

• Conditions: Cervix Cancer; Cervical Cancer; Cervical Dysplasia; Cervical Lesion; Cervical Neoplasm; Cervical Disease
• Interventions: Diagnostic Test: Dynamic Spectral Imaging (DYSIS)

• Registration Number: NCT04249856
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Status Verified: 2019-12
• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-01-31
• Last Update Posted: 2020-01-31
• Primary Completion: 2020-06-01
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3000

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women examined by colposcopy	Dynamic Spectral Imaging (DYSIS)	Women referred to colposcopy at our facilities who met inclusion criteria

Primary Outcome Measures

Name	Time	Method
Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB)	when the histological report is available - typically 4 weeks after the biopsy was taken.	The proportion of women who are found with a histological CIN2+ diagnosis in the cervical punch biopsy from the area chosen by the colposcopist before the DSI-map became visible (will be referred to as the Colposcopy directed biopsy (CDB)).; The diagnosis of the biopsy will be recorded when the histological report is available.; Further treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.
Proportion of women found with a histological diagnosis of CIN2 or worse in 2 additional random biopsies	when the histological report is available - typically 4 weeks after the biopsy was taken.	The amount of women who are found with a histological CIN2+ diagnosis in cervical punch biopsies taken from 2 additional areas besides the CDB and the DSI-directed areas.; The diagnosis of the biopsy will be recorded when the histological report is available.; Further treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.
Proportion of women found with a histological diagnosis of CIN2 or worse in DSI-directed biopsies	when the histological report is available - typically 4 weeks after the biopsy was taken.	The proportion of women who are found with a histological CIN2+ diagnosis in cervical punch biopsy taken from the worst area indicated by the DSI-map (referred to as the DSI-directed biopsy) The diagnosis of the biopsy will be recorded when the histological report is available.; Further treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.

Secondary Outcome Measures

Name	Time	Method
Concordance of cervical punch biopsies and cone biopsy	When both histological reports were available these were compared.	Comparing the histological diagnosis of the cervical punch biopsies to the cone biopsy, in women who are referred for conization based on the histological outcome of the colposcopy procedure.

Trial Locations

Locations (4)

Private Gynaecology Clinic; 🇩🇰 Aarhus, Denmark

Horsens Regional Hospital; 🇩🇰 Horsens, Denmark

Randers Regional Hospital; 🇩🇰 Randers, Danmark, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark