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Clinical Trials/NCT02881229
NCT02881229
Terminated
Not Applicable

Open Ended Chart Review of Adult Women Presenting to the Vulvar Mucosal Specialty Clinic at Northwestern University Department of Dermatology

Northwestern University1 site in 1 country719 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vulvar Disease
Sponsor
Northwestern University
Enrollment
719
Locations
1
Primary Endpoint
Clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in the management of vulvar disease
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

This study aims to develop a clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in management of vulvar disease.

Detailed Description

Vulvar disorders are common, but their frequency and importance are often under-recognized. The spectrum of vulvar disease is vast and includes congenital malformations, inflammatory mucocutaneous diseases, blistering and erosive diseases, benign and malignant tumors, autoimmune disorders, infectious diseases, and various idiopathic conditions. Evaluation and management of genital complaints and dermatoses are complicated by the frequent multifactorial nature of vulvar symptoms and variable clinical expressions of disease on the vulva. In many cases, empiric treatment is instituted in the absence of a definitive diagnosis. Of note, expertise in the diagnosis and management of vulvar disorders is often lacking on the parts of gynecology, dermatology and primary care physicians. The investigators seek to analyze the data on this patient population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of the Northwestern Memorial Faculty Foundation (NMFF) to better define the clinical spectrum of vulvar disease. The investigators will also assess approaches to the diagnosis and management of patients with vulvar disease with attention given to clinical outcome and the impact on quality of life. This information with help the investigators to better understand the scope of care these patients currently receive, to identify deficits in current practice, and to advance potential new standards of care.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
January 6, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephanie Rangel

Research Assistant Professor of Dermatology

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Patients 18 years of age or older
  • Patients seen at Northwestern Medical Group Department of Dermatology who were seen by Dr. Bethanee Schlosser and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings.

Exclusion Criteria

  • Patients who refuse complete mucocutaneous examination.
  • Patients who refuse recommended diagnostic procedures.
  • Pregnant women or prisoners.

Outcomes

Primary Outcomes

Clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in the management of vulvar disease

Time Frame: Through study completion, an average of 1 year

Secondary Outcomes

  • Potential prognostic indicators in various vulvar conditions(Through study completion, an average of 1 yea)

Study Sites (1)

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