Cervical DysplasiaNCT04249856
Colposcopy and Dynamic Spectral Imaging (DSI)
An observational study of Cervical Dysplasia and Cervical Disease, run by University of Aarhus at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dysplasia, Cervical Disease, Cervical Lesion
- What is being tested?
- Dynamic Spectral Imaging (DYSIS)
- How many people
- 3,000 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Feb 2017to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Cervical biopsies taken within the last 6 months
- Previous cone procedure
- Currently pregnant
- Pregnant within the last 6 months
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites, 2 recruiting
- Withdrawn
Aalborg University Hospital
Aalborg, 9000
- Completed
Private Gynaecology Clinic
Aarhus, 8000
- Recruiting
Horsens Regional Hospital
Horsens, 8700
Christina B Kristensen, MD
- Recruiting
Randers Regional Hospital
Randers, Danmark, 8930
Berit B Booth, 28587858, berit.booth@auh.rm.dk
About this study
Official title: Does Dynamic Spectral Imaging (DSI) Colposcopy Improve the Diagnostics of Cervical Dysplasia Compared to Standard Colposcopy
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.
Read the 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:
- The area the colposcopists views as the worst before the DSI-map is seen. Colposcopy-Directed Biopsy (CDB)
- The area indicated as the worst by the DSI-map (DSI-directed biopsy)
- additional biopsy
- additional biopsy All biopsies are placed in separate containers and analysed separately by specialized pathologists.
- Conditions
- Cervical Dysplasia, Cervical Disease, Cervical Lesion, Cervix Cancer, Cervical Cancer, Cervical Neoplasm
- Being tested
- Dynamic Spectral Imaging (DYSIS)
- Keywords
- Colposcopy, Dynamic Spectral Imaging, DySIS, Colposcopy Directed Biopsy
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Diseases, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Women examined by colposcopy | Women referred to colposcopy at our facilities who met inclusion criteria Receives: Diagnostic Test: Dynamic Spectral Imaging (DYSIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: when the histological report is available - typically 4 weeks after the biopsy was taken.
Secondary outcomes (1)
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.
Measured: When both histological reports were available these were compared.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Feb 2017
- Primary completion1 Jun 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berit B Booth, MD, Principal investigator, University of AarhusPinar Bor, MD, PhD, Study chair, Randers Regional HospitalLone K Petersen, MD, Med.Sc.D., Study chair, Odense University HospitalJan Blaakaer, MD, Med.Sc.D., Study chair, Odense University HospitalKatja Dahl, MD, PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249856
- Sponsor's protocol ID
- DSIcolposcopy_DK
- Status last verified
- Dec 2019
- First submitted
- 23 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34798899Booth 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.
PubMed 33435974
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dynamic Spectral Imaging (DSI) Colposcopy Improve the Diagnostics of Cervical Dysplasia Compared to Standard Colposcopy
- ClinicalTrials.gov ID
- NCT04249856
- Acronym / sponsor ID
- DSIcolposcopy_DK
- Conditions
- Cervical Dysplasia, Cervical Disease, Cervical Lesion, Cervix Cancer, Cervical Cancer, Cervical Neoplasm
- Keywords
- Colposcopy, Dynamic Spectral Imaging, DySIS, Colposcopy Directed Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The area the colposcopists views as the worst before the DSI-map is seen. Colposcopy-Directed Biopsy (CDB)
- The area indicated as the worst by the DSI-map (DSI-directed biopsy)
- additional biopsy
- additional biopsy All biopsies are placed in separate containers and analysed separately by specialized pathologists.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women examined by colposcopy | – | Diagnostic Test: Dynamic Spectral Imaging (DYSIS)Women referred to colposcopy at our facilities who met inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- Cervical biopsies taken within the last 6 months
- Previous cone procedure
- Currently pregnant
- Pregnant within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Spectral Imaging (DYSIS)Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS) | Diagnostic test | Women examined by colposcopy |
Primary outcome
Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB)
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Concordance of cervical punch biopsies and cone biopsy
Time frame: When both histological reports were available these were compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 34798899Jespersen 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.
- Derived from this study: PubMed 33435974Booth 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cervical Dysplasia
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
Not yet recruiting
C2001P-CS3: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV
Human Papillomavirus (HPV), HPV Associated Cancers
Not yet recruitingObservational study
Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit
Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms
Active, not recruitingObservational study
Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation
Not yet recruitingPhase 2
Exploratory Study of the Efficacy of HAL-PDT in CIN 3
Cervical Intraepithelial Neoplasia Grade 3
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit B Booth, MD principal investigator
University of Aarhus
Pinar Bor, MD, PhD study chair
Randers Regional Hospital
Lone K Petersen, MD, Med.Sc.D. study chair
Odense University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dysplasia and Cervical Disease, run by University of Aarhus at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berit B Booth, MD (+4528587858, berit.booth@auh.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB) (time frame: when the histological report is available - typically 4 weeks after the biopsy was taken.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249856, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.