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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women examined by colposcopy | Women referred to colposcopy at our facilities who met inclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Spectral Imaging (DYSIS) | Diagnostic Test | Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Berit B Booth, MD | Contact | +4528587858 | berit.booth@auh.rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Berit B Booth, MD | University of Aarhus | Principal Investigator |
| Pinar Bor, MD, PhD | Randers Regional Hospital | Study Chair |
| Lone K Petersen, MD, Med.Sc.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Randers Regional Hospital | Recruiting | Randers | Danmark | 8930 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34798899 | Derived | 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. | |
| 33435974 | Derived | 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. |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002577 | Uterine Cervical Diseases |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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Cervical punch biopsies
| Odense University Hospital |
| Study Chair |
| Jan Blaakaer, MD, Med.Sc.D. | Odense University Hospital | Study Chair |
| Katja Dahl, MD, PhD | Aarhus University Hospital | Study Chair |
| Aalborg University Hospital | Withdrawn | Aalborg | 9000 | Denmark |
| Private Gynaecology Clinic | Completed | Aarhus | 8000 | Denmark |
| Horsens Regional Hospital | Recruiting | Horsens | 8700 | Denmark |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |