Brief Title
Colposcopy and Dynamic Spectral Imaging (DSI)
Official Title
Does Dynamic Spectral Imaging (DSI) Colposcopy Improve the Diagnostics of Cervical Dysplasia Compared to Standard Colposcopy
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.
Study Type
Observational
Primary Outcome
Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB)
Secondary Outcome
Concordance of cervical punch biopsies and cone biopsy
Condition
Cervical Dysplasia
Intervention
Dynamic Spectral Imaging (DYSIS)
Study Arms / Comparison Groups
Women examined by colposcopy
Description: Women referred to colposcopy at our facilities who met inclusion criteria
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
3000
Start Date
February 1, 2017
Completion Date
October 31, 2020
Primary Completion Date
June 1, 2020
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Berit B Booth, MD, +4528587858, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04249856
Organization ID
DSIcolposcopy_DK
Responsible Party
Sponsor
Study Sponsor
University of Aarhus
Study Sponsor
Berit B Booth, MD, Principal Investigator, University of Aarhus
Verification Date
December 2019