Gynecologic Extramammary Paget's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-19

Study Completion Date

2050-12-31

Brief Summary

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In addition to evaluating treatment outcomes, tissue samples and swabs will be collected as part of this study to allow physicians to better understand Extramammary Paget's Disease (EMPD). The researchers also want to learn more about the microorganisms (microbiome) that live on or near the areas of skin affected by EMPD, in order to better understand this condition.

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Detailed Description

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This is a prospective cohort study. Patients with Extramammary Paget's Disease (EMPD), specifically women with vulvar/perianal Paget's disease, will be identified during presentation to either the Dermatology Department or Gynecologic Surgery department at Mayo Clinic.

During physical exam, the patients will undergo skin/rectum/vagina cultures to evaluate the microbiome in these patients. The patients will be entered into the established care pathway for EMPD. They will be asked to complete sexual health questionnaires including: The Women's Health Clinical Questionnaires include the Menopause Rating Scale (MRS)1, Perceived Stress Scale2, Brief Resilience Scale (BRS)3, LASA Quality of Life Assessment4, Female Sexual Function Index (FSFI)5, Female Sexual Distress Scale-Revised6, Kansas Marital Satisfaction Scale7, and Pittsburgh Sleep Quality Index (PSQI)8.

The patients will be referred to Women's Health Clinic as part of the care pathway and will undergo preoperative genital sensory testing (GST) which measures sensation of the clitoris, vulva, and vagina. The patients will have a Dermatology consultation and Moh's micrographic procedure as indicated. If choosing to proceed with surgical intervention, the patients will then undergo an excisional procedure with the Department of Gynecologic surgery. Swabs, urine and tissue will be collected prior to procedures or surgery for microbiome analysis.

Conditions

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Extramammary Paget's Disease Extramammary Paget Disease Paget Disease, Extramammary Extramammary Paget's Disease of Vulva (Diagnosis) Extramammary Paget's Disease of Vagina (Diagnosis) Extramammary Paget's Disease Vulva Invasive Extramammary Paget's Disease of Anus (Diagnosis) Extramammary Paget's Disease of Anal Canal (Diagnosis) Extramammary Paget's Disease of Skin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Registry Observational Study

All women presenting for evaluation of Extramammary Paget's Disease (EMPD) at Mayo Clinic in Rochester MN.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Females
* Age 18 years or older
* Diagnosed with primary or recurrent EMPD of vulva and/or perianal region of the body
* Willing and able to provide signed informed consent