Colposcopy and Dynamic Spectral Imaging (DSI)

NCT04249856UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

3000

Start Date

2017-02-01

Completion Date

2020-06-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Dynamic Spectral Imaging (DYSIS)

Conditions

Cervical DysplasiaCervical DiseaseCervical LesionCervix CancerCervical CancerCervical Neoplasm

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

Time frame: when the histological report is available - typically 4 weeks after the biopsy was taken.

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.

Time frame: when the histological report is available - typically 4 weeks after the biopsy was taken.

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.

Time frame: when the histological report is available - typically 4 weeks after the biopsy was taken.

Secondary Outcomes

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.

Time frame: When both histological reports were available these were compared.

Locations

Randers Regional Hospital, Randers, Denmark

Aalborg University Hospital, Aalborg, Denmark

Private Gynaecology Clinic, Aarhus, Denmark

Horsens Regional Hospital, Horsens, Denmark

Linked Papers

2021-11-19

Can biopsies be omitted after normal colposcopy in women referred with low-grade cervical cytology? A prospective cohort study

Abstract Background Controversy surrounds whether women with low-risk cytology screening results but a normal colposcopic assessment should have random biopsies taken. The aim of this study was to determine the yield of CIN2+ from one to four cervical biopsies in women with cytology of LSIL or ASCUS and a normal colposcopic impression. Methods Between January 2017 and September 2020, women over 18 years old referred for colposcopic examination due to either an abnormal smear (ASCUS+) or follow-up after previous cervical intraepithelial neoplasia (CIN) were invited to participate in the study. All study participants underwent colposcopic examination and had four biopsies taken. The biopsies were analyzed separately. Results In total, 1327 women with abnormal cervical cancer screening results or attending follow-up after a previous CIN diagnosis were enrolled in the study and examined by colposcopy. Of these, 173 were newly referred with cytology of LSIL or ASCUS and had a normal colposcopic impression and four adequate biopsies. Of these, 22.0% were diagnosed with CIN2+. When combining the results of the four biopsies, we found a 100% relative increase in CIN2+ cases compared to using only one biopsy (from 11.0% to 22.0%, P = 0.006). Conclusion As we found CIN2+ from random cervical biopsies in 22.0% of women with cytology of LSIL or ASCUS who had a normal colposcopic impression, we advocate performing four random cervical biopsies at the squamocolumnar junction in such women. Trial registration NCT04249856, January 31 2020 (retrospectively registered).

2021-01-12

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

Abstract Background Colposcopy serves as a subjective examination of the cervix with low sensitivity to detect cervical intraepithelial dysplasia (CIN) grade 2 or worse (CIN2 +). Dynamic spectral imaging (DSI) colposcopy has been developed to provide an objective element to cervix examinations and has been proven to increase sensitivity of detecting CIN2 + . We aimed to assess the performance of the DSI color map and compared it to histological diagnoses of cervical biopsies in determining the CIN grade present. Methods Women were included in a consecutive, prospective manner at Randers Regional Hospital, Denmark. Women were eligible to participate if they were referred for colposcopy due to abnormal cervical smear (threshold:  ≥ ASCUS) or follow-up after previously diagnosed CIN. All women had four biopsies taken, one directed by colposcopists alone prior to viewing the DSI color map, one directed by the worst color on the respective DSI color map, and two additional biopsies. All biopsies were analyzed separately. We calculated sensitivity, specificity, positive predictive values, and negative predictive values (NPVs) with 95% confidence intervals (CIs). Results A total of 800 women were recruited. Of these, 529 (66.1%) were eligible for inclusion. The sensitivity of the DSI color map was found to be 48.1% (95% CI 41.1–55.1) in finding CIN grade 2 or worse (CIN2 +) when compared to the histological diagnosis of the DSI directed biopsy. This was 42.5% (95% CI 36.7–48.5) when compared to the final histological diagnosis of all four cervical biopsies and with an NPV of 53.5% (95% CI 50.5–56.5). Conclusion The worst color indicated by the DSI map might not consistently reflect the true grade of cervical dysplasia present. Thus, even though the DSI color map indicates low-grade changes, colposcopists should still consider taking biopsies from the area as high-grade changes might be present. Trial registration: NCT04249856, January 31 2020 (retrospectively registered).

Linked Investigators

Berit B. Booth