Vulvar Paget Disease

November 9, 2020 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • East Flanders
      • Ghent, East Flanders, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with vulvar paget disease

Description

Inclusion Criteria:

  • Vulvar Paget disease

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Vulvar Paget Disease
Women with vulvar paget disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of complications after the treatment of vulvar Paget disease
Time Frame: Max. 10 years after treatment
Number of complications after treatment
Max. 10 years after treatment
Type of complications after the treatment of vulvar Paget disease
Time Frame: Max. 10 years after treatment
Type of complications after treatment
Max. 10 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 25, 2018

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

April 1, 2019

First Posted (ACTUAL)

April 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • EC/2018/1164

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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