Clincosm LogoSign in Get a demo

Vulvar Paget Disease

Sponsor
University Hospital, Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT03900975
Collaborator
(none)
8
Enrollment
1
Location
22.2
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Analyses of the Outcome of a Treatment of Vulvar Paget Disease
    Actual Study Start Date :
    Sep 25, 2018
    Actual Primary Completion Date :
    Jun 30, 2020
    Actual Study Completion Date :
    Jul 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Vulvar Paget Disease

    Women with vulvar paget disease

    Outcome Measures

    Primary Outcome Measures

    1. Number of complications after the treatment of vulvar Paget disease [Max. 10 years after treatment]

      Number of complications after treatment

    2. Type of complications after the treatment of vulvar Paget disease [Max. 10 years after treatment]

      Type of complications after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Vulvar Paget disease
    Exclusion Criteria:
    • No exclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ghent University Hospital Ghent East Flanders Belgium 9000

    Sponsors and Collaborators

    • University Hospital, Ghent

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Ghent
    ClinicalTrials.gov Identifier:
    NCT03900975
    Other Study ID Numbers:
    • EC/2018/1164
    First Posted:
    Apr 3, 2019
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 10, 2020