Vulvar Paget's DiseaseNCT03900975
Vulvar Paget Disease
An observational study of Vulvar Paget's Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Paget's Disease
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Sep 2018to 31 Jul 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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with vulvar paget disease
Who may be able to join
- Vulvar Paget disease
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analyses of the Outcome of a Treatment of Vulvar Paget Disease
In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.
Read the detailed description
In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.
All the information of the patients will be gathered retrospectively from their medical file , after they gave their consent.
- Conditions
- Vulvar Paget's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vulvar Paget Disease | Women with vulvar paget disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications after the treatment of vulvar Paget disease
Number of complications after treatment
Measured: Max. 10 years after treatment
Type of complications after the treatment of vulvar Paget disease
Type of complications after treatment
Measured: Max. 10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start25 Sep 2018
- Primary completion30 Jun 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Paget's DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900975
- Sponsor's protocol ID
- EC/2018/1164
- Status last verified
- Nov 2020
- First submitted
- 14 Dec 2018
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyses of the Outcome of a Treatment of Vulvar Paget Disease
- ClinicalTrials.gov ID
- NCT03900975
- Acronym / sponsor ID
- EC/2018/1164
- Conditions
- Vulvar Paget's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 3 Apr 2019 (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.
In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.
Detailed description
In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.
All the information of the patients will be gathered retrospectively from their medical file , after they gave their consent.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vulvar Paget Disease | – | –Women with vulvar paget disease |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with vulvar paget disease
Key inclusion criteria (1 listed)
- Vulvar Paget disease
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of complications after the treatment of vulvar Paget disease
Time frame: Max. 10 years after treatment
Number of complications after treatment
Type of complications after the treatment of vulvar Paget disease
Time frame: Max. 10 years after treatment
Type of complications after treatment
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 10 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvar Paget's Disease, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 1 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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Number of complications after the treatment of vulvar Paget disease (time frame: Max. 10 years after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2020.