Cervical Cancer, Cervical Disease, Cervical Dysplasia, Cervical Lesion, Cervical Neoplasm, Cervix Cancer
Conditions
Keywords
Colposcopy, Dynamic Spectral Imaging, DySIS, Colposcopy Directed Biopsy
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.
Interventions
DIAGNOSTIC_TESTDynamic Spectral Imaging (DYSIS)
Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)
Sponsors
University of Aarhus
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Contacts
Primary ContactBerit B Booth, MD
Outcome results
None listed