Clinical trial NCT04249856: Colposcopy and Dynamic Spectral Imaging (DSI)
Official title: Does Dynamic Spectral Imaging (DSI) Colposcopy Improve the Diagnostics of Cervical Dysplasia Compared to Standard Colposcopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Dysplasia
Cervical Disease
Cervical Lesion
Cervix Cancer
Cervical Cancer
Cervical Neoplasm
Keywords: Colposcopy
Dynamic Spectral Imaging, DySIS
Colposcopy Directed Biopsy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women above the age of 18 who are referred for colposcopy due to an abnormal cervical smear (ASCUS, LSIL, ASC-H, HSIL, ACG or CIS) or as follow up to previously diagnosed CIN. The women cannot be included if they have had cervical biopsies taken within the last 6 months, have previously had a cone biopsy taken, are currently pregnant or have been pregnant within the last 3 months.

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.

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

Primary outcomes:
measure: Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB)
timeFrame: when the histological report is available - typically 4 weeks after the biopsy was taken.
measure: Proportion of women found with a histological diagnosis of CIN2 or worse in DSI-directed biopsies
timeFrame: when the histological report is available - typically 4 weeks after the biopsy was taken.
measure: Proportion of women found with a histological diagnosis of CIN2 or worse in 2 additional random biopsies
timeFrame: when the histological report is available - typically 4 weeks after the biopsy was taken.
Secondary outcomes:
measure: Concordance of cervical punch biopsies and cone biopsy
timeFrame: When both histological reports were available these were compared.
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Randers Regional Hospital
state: Danmark
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Private Gynaecology Clinic
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
Study officials:
affiliation: University of Aarhus
name: Berit B Booth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Randers Regional Hospital
name: Pinar Bor, MD, PhD
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Lone K Petersen, MD, Med.Sc.D.
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Jan Blaakaer, MD, Med.Sc.D.
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Katja Dahl, MD, PhD
role: STUDY_CHAIR
References:
citation: Jespersen MM, Booth BB, Petersen LK. Can biopsies be omitted after normal colposcopy in women referred with low-grade cervical cytology? A prospective cohort study. BMC Womens Health. 2021 Nov 19;21(1):394. doi: 10.1186/s12905-021-01537-5.
citation: Booth BB, Petersen LK, Blaakaer J, Johansen T, Mertz H, Dahl K, Bor P. Can the dynamic spectral imaging (DSI) color map improve colposcopy examination for precancerous cervical lesions? A prospective evaluation of the DSI color map in a multi-biopsy clinical setting. BMC Womens Health. 2021 Jan 12;21(1):21. doi: 10.1186/s12905-020-01169-1.