Colposcopy and Dynamic Spectral Imaging (DSI)

Cervical Cancer Clinical Trial

Official title:

Does Dynamic Spectral Imaging (DSI) Colposcopy Improve the Diagnostics of Cervical Dysplasia Compared to Standard Colposcopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249856
• Other study ID #: DSIcolposcopy_DK
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: December 2019
• Source: University of Aarhus
• Contact: Berit B Booth, MD
• Phone: +4528587858
• Email: berit.booth[@]auh.rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 31, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Disease
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Cervical Lesion
• Cervical Neoplasm
• Cervix Cancer
• Uterine Cervical Diseases
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Dynamic Spectral Imaging (DYSIS)
Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Private Gynaecology Clinic	Aarhus
Denmark	Horsens Regional Hospital	Horsens
Denmark	Randers Regional Hospital	Randers	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB)	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.	when the histological report is available - typically 4 weeks after the biopsy was taken.
Primary	Proportion of women found with a histological diagnosis of CIN2 or worse in DSI-directed biopsies	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.	when the histological report is available - typically 4 weeks after the biopsy was taken.
Primary	Proportion of women found with a histological diagnosis of CIN2 or worse in 2 additional random biopsies	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.	when the histological report is available - typically 4 weeks after the biopsy was taken.
Secondary	Concordance of cervical punch biopsies and cone biopsy	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.	When both histological reports were available these were compared.

External Links

•   Project website (In danish only)