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Trial record 22 of 25 for:    "Lichen Sclerosus"

Vulvar Mucosal Specialty Clinic Chart Review

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ClinicalTrials.gov Identifier: NCT02881229
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Bethanee Schlosser, Northwestern University

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.

Condition or disease
Vulvar Disease Lichen Sclerosus Lichen Planus Vulvodynia

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Open Ended Chart Review of Adult Women Presenting to the Vulvar Mucosal Specialty Clinic at Northwestern University Department of Dermatology
Study Start Date : April 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Women in the Vulvar Specialty Clinic
Information will be collected from all patients presenting with vulvar complaints who have been seen by Dr. Schlosser in the Vulvar Mucosal Specialty Clinic at Northwestern Medical Group.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Potential prognostic indicators in various vulvar conditions [ Time Frame: Through study completion, an average of 1 yea ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women seen at the Vulvar Mucosal Specialty Clinic
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881229


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Bethanee J Schlosser, MD, PhD Northwestern University

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Responsible Party: Bethanee Schlosser, Assisstant Professor in Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT02881229     History of Changes
Other Study ID Numbers: STU00001056
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vulvodynia
Vulvar Diseases
Lichen Planus
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Genital Diseases, Female