Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2017-02-01
2020-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Women examined by colposcopy
Women referred to colposcopy at our facilities who met inclusion criteria
Dynamic Spectral Imaging (DYSIS)
Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)
Interventions
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Dynamic Spectral Imaging (DYSIS)
Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous cone procedure
* Currently pregnant
* Pregnant within the last 6 months
18 Years
FEMALE
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Berit B Booth, MD
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Pinar Bor, MD, PhD
Role: STUDY_CHAIR
Randers Regional Hospital
Lone K Petersen, MD, Med.Sc.D.
Role: STUDY_CHAIR
Odense University Hospital
Jan Blaakaer, MD, Med.Sc.D.
Role: STUDY_CHAIR
Odense University Hospital
Katja Dahl, MD, PhD
Role: STUDY_CHAIR
Aarhus University Hospital
Locations
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Randers Regional Hospital
Randers, Danmark, Denmark
Aalborg University Hospital
Aalborg, , Denmark
Private Gynaecology Clinic
Aarhus, , Denmark
Horsens Regional Hospital
Horsens, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Berit B Booth
Role: primary
Christina B Kristensen, MD
Role: primary
References
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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.
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.
Other Identifiers
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DSIcolposcopy_DK
Identifier Type: -
Identifier Source: org_study_id