Vulvar Paget Disease

Vulvar Paget's Disease Clinical Trial

Official title:

Analyses of the Outcome of a Treatment of Vulvar Paget Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900975
• Other study ID #: EC/2018/1164
• Status: Completed
• Start date: September 25, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Vulvar Paget disease

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Vulvar Paget's Disease

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications after the treatment of vulvar Paget disease	Number of complications after treatment	Max. 10 years after treatment
Primary	Type of complications after the treatment of vulvar Paget disease	Type of complications after treatment	Max. 10 years after treatment