Cervical DysplasiaNCT04298957
See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia
A study testing Cone biopsy in people with Cervical Dysplasia and Cervical Lesion, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The study will investigate if implementation of "see and treat" in the outpatient clinic can optimize the diagnosis, clinical follow-up and treatment of older women with positive cervical screening test. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Cervical Dysplasia, Cervical Lesion, Cervix Disease
- What is being tested?
- Cone biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 3 sitesDenmark
- Study dates
- 13 Mar 2019to 31 Jan 2022
- Phase
- Interventional
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥ 45 years with a positive screening test (abnormal cytology and/or persistence HPV positive) who are referred to the Department of Obstetrics and Gynecology.
- Type 2 or 3 transformation zone (a partly or invisible transformation zone).
Who cannot join
- Type 1 transformation zone (fully visible)
- Current or previous diagnosis of cervical cancer.
- Pregnancy or pregnancy wish.
- Previously cone biopsy
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Horsens Regional Hospital
Horsens, Jutland, 8700
Randers Regional Hospital
Randers, Jutland, 8930
Viborg Regional Hospital
Viborg, Jutland, 8800
About this study
The study will investigate if implementation of "see and treat" in the outpatient clinic can optimize the diagnosis, clinical follow-up and treatment of older women with positive cervical screening test.
Read the detailed description
In Denmark, 370 women are diagnosed with cervical cancer every year and approximately 100 women die from the disease. Young women can be protected with the HPV vaccine, but it will take decades before the vaccine has an effect on older women. Women who are HPV positive have a risk of developing severe dysplasia of 25-55% within 10 years. Compared to younger women, older women are also more likely to be diagnosed with advanced-stage disease and their mortality is high. Due to retraction of the transformation zone into the cervical canal and atrophy of the mucosa the performance of colposcopy is low. Furthermore, the sensitivity of cytology decreases with age. This makes it very difficult to obtain sufficient biopsies and therefore postmenopausal women are often required to undergo colposcopy two to three times. Waiting for a final diagnosis and treatment not only has a large mental and practical impact on the women themselves, but it is also an economic burden for the health care system.
"See and treat" is a procedure that involves cervical cytology and HPV test, a colposcopy, cervical biopsies, and finally a loop electrosurgical excisional procedure by which the transformation zone is removed. This approach allows women to be diagnosed and treated in one visit.
In this project, the aim is to investigate if the implementation of "see and treat" in a gynecological outpatient clinic can optimize the diagnostics, clinical follow-up, and treatment of older women with abnormal cervical cytology or HPV-infection.
Participants Women aged ≥ 45 years with cervical dysplasia and/or a positive HPV test are referred from the general practitioner to the gynecological department.
Procedure At each inclusion site, the local project manager evaluates all the referred women for possible inclusion. Project information is sent either by e-mail or letter to eligible women. At the outpatient clinic, the eligible women will be informed about the project and asked to sign an informed consent form regarding their participation in the project.
If the eligible women agree to participate a physician in the outpatient clinic will obtain a cervical smear (i.e. cytology and Human Papillomavirus (HPV) test) and perform colposcopy and take four random biopsies. If the transformation zone (TZ) is partly visible or not visible a cone biopsy will be performed in local anesthesia (Citanest).
If the participant meet the exclusion criteria or declines to participate standard treatment will be offered (colposcopy and biopsies).
The included patients will be followed up with an HPV test after 6 months.
- Conditions
- Cervical Dysplasia, Cervical Lesion, Cervix Disease
- Being tested
- Cone biopsy
- Keywords
- Cone biopsy, Colposcopy, See and treat
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone biopsyProcedure or surgery
Cone biopsy if transformation Zone (TZ) 2 or TZ 3
| Study group | Role | What they receive |
|---|---|---|
| See and treat | Other | Cone biopsi is offered to women age ≥ 45 years referred to Department of Obstetrics and Gynecology due to a positive cervical screening test and partly or invisible transformation zone. Receives: Procedure: Cone biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical intraepithelial neoplasia ≥ grade 2 (CIN2+) lesion after referral with a positive cervical screening test
The prevalence of CIN2+ lesions in women ≥45 years included in the study
Measured: The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
Concordance between cytology and histology
Concordance between cytology, biopsies and cone biopsy in the ability to detect CIN2+ changes
Measured: The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
Clearance of HPV
Clearance rate of HPV after 6 months
Measured: This will be available 7 months after inclusion.
Complication rate
Complication rate of bleeding, infection and/or stenosis
Measured: Complication rate will be evaluated 6 months after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start13 Mar 2019
- Primary completion30 Jun 2021
- Study completion31 Jan 2022
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Line W Gustafson, MD, Principal investigator, Randers Regional Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298957
- Sponsor's protocol ID
- 172230
- Status last verified
- Apr 2021
- First submitted
- 3 Feb 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset generated and analyzed in this study are not available for the public due to Danish legislation.
Publications
Binderup KO, Boers J, Gustafson LW, Andersen B, Petersen LK, Bor P, Gribnau J, Quint WGV, Van Den Munckhof H, Tranberg M, Hammer A. DNA-Methylation for Risk-Stratification of Women Without a Fully Visible Transformation Zone at Colposcopy: A Cross-Sectional Study. BJOG. 2025 Jul 14. doi: 10.1111/1471-0528.18288. Online ahead of print.
PubMed 40654017Hammer A, Gustafson LW, Christensen PN, Brondum R, Andersen B, Andersen RH, Tranberg M. Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience. Cancer Med. 2020 Nov;9(21):8235-8242. doi: 10.1002/cam4.3399. Epub 2020 Sep 7.
PubMed 32894896
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia
- ClinicalTrials.gov ID
- NCT04298957
- Acronym / sponsor ID
- 172230
- Conditions
- Cervical Dysplasia, Cervical Lesion, Cervix Disease
- Keywords
- Cone biopsy, Colposcopy, See and treat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 6 Mar 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.
The study will investigate if implementation of "see and treat" in the outpatient clinic can optimize the diagnosis, clinical follow-up and treatment of older women with positive cervical screening test.
Detailed description
In Denmark, 370 women are diagnosed with cervical cancer every year and approximately 100 women die from the disease. Young women can be protected with the HPV vaccine, but it will take decades before the vaccine has an effect on older women. Women who are HPV positive have a risk of developing severe dysplasia of 25-55% within 10 years. Compared to younger women, older women are also more likely to be diagnosed with advanced-stage disease and their mortality is high. Due to retraction of the transformation zone into the cervical canal and atrophy of the mucosa the performance of colposcopy is low. Furthermore, the sensitivity of cytology decreases with age. This makes it very difficult to obtain sufficient biopsies and therefore postmenopausal women are often required to undergo colposcopy two to three times. Waiting for a final diagnosis and treatment not only has a large mental and practical impact on the women themselves, but it is also an economic burden for the health care system.
"See and treat" is a procedure that involves cervical cytology and HPV test, a colposcopy, cervical biopsies, and finally a loop electrosurgical excisional procedure by which the transformation zone is removed. This approach allows women to be diagnosed and treated in one visit.
In this project, the aim is to investigate if the implementation of "see and treat" in a gynecological outpatient clinic can optimize the diagnostics, clinical follow-up, and treatment of older women with abnormal cervical cytology or HPV-infection.
Participants Women aged ≥ 45 years with cervical dysplasia and/or a positive HPV test are referred from the general practitioner to the gynecological department.
Procedure At each inclusion site, the local project manager evaluates all the referred women for possible inclusion. Project information is sent either by e-mail or letter to eligible women. At the outpatient clinic, the eligible women will be informed about the project and asked to sign an informed consent form regarding their participation in the project.
If the eligible women agree to participate a physician in the outpatient clinic will obtain a cervical smear (i.e. cytology and Human Papillomavirus (HPV) test) and perform colposcopy and take four random biopsies. If the transformation zone (TZ) is partly visible or not visible a cone biopsy will be performed in local anesthesia (Citanest).
If the participant meet the exclusion criteria or declines to participate standard treatment will be offered (colposcopy and biopsies).
The included patients will be followed up with an HPV test after 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| See and treat | Other | Procedure: Cone biopsyCone biopsi is offered to women age ≥ 45 years referred to Department of Obstetrics and Gynecology due to a positive cervical screening test and partly or invisible transformation zone. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women ≥ 45 years with a positive screening test (abnormal cytology and/or persistence HPV positive) who are referred to the Department of Obstetrics and Gynecology.
- Type 2 or 3 transformation zone (a partly or invisible transformation zone).
Key exclusion criteria (4 listed)
- Type 1 transformation zone (fully visible)
- Current or previous diagnosis of cervical cancer.
- Pregnancy or pregnancy wish.
- Previously cone biopsy
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 |
|---|---|---|
| Cone biopsyCone biopsy if transformation Zone (TZ) 2 or TZ 3 | Procedure or surgery | See and treat |
Primary outcome
Cervical intraepithelial neoplasia ≥ grade 2 (CIN2+) lesion after referral with a positive cervical screening test
Time frame: The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
The prevalence of CIN2+ lesions in women ≥45 years included in the study
Concordance between cytology and histology
Time frame: The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
Concordance between cytology, biopsies and cone biopsy in the ability to detect CIN2+ changes
Clearance of HPV
Time frame: This will be available 7 months after inclusion.
Clearance rate of HPV after 6 months
Complication rate
Time frame: Complication rate will be evaluated 6 months after inclusion.
Complication rate of bleeding, infection and/or stenosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 40654017Binderup KO, Boers J, Gustafson LW, Andersen B, Petersen LK, Bor P, Gribnau J, Quint WGV, Van Den Munckhof H, Tranberg M, Hammer A. DNA-Methylation for Risk-Stratification of Women Without a Fully Visible Transformation Zone at Colposcopy: A Cross-Sectional Study. BJOG. 2025 Jul 14. doi: 10.1111/1471-0528.18288. Online ahead of print.
- Derived from this study: PubMed 32894896Hammer A, Gustafson LW, Christensen PN, Brondum R, Andersen B, Andersen RH, Tranberg M. Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience. Cancer Med. 2020 Nov;9(21):8235-8242. doi: 10.1002/cam4.3399. Epub 2020 Sep 7.
- Individual participant dataSharing planned: No. The dataset generated and analyzed in this study are not available for the public due to Danish legislation.
Related trials for Cervical Dysplasia
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
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.
Line W Gustafson, MD principal investigator
Randers Regional Hospital and Aarhus University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone biopsy in people with Cervical Dysplasia and Cervical Lesion, run by University of Aarhus at 3 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: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical intraepithelial neoplasia ≥ grade 2 (CIN2+) lesion after referral with a positive cervical screening test (time frame: The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.). The study lists 4 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 NCT04298957, 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 18 May 2022.