Gynecologic Extramammary Paget's Disease

Extramammary Paget Disease Clinical Trial

Official title:

Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03564483
• Other study ID #: 17-007532
• Status: Recruiting
• Start date: February 19, 2018
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: Maureen A. Lemens, R.N.
• Phone: 507-293-1487
• Email: lemens.maureen[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Males

• Diagnosis of Paget's Disease in body areas other than vulvar or perianal region

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect prospective data including outcomes and long-term survival in women with extramammary Paget's disease (EMPD).	Prospective data including patient demographic information, surgical outcomes, surgical morbidity, recurrence, and long-term survival in extramammary Paget's disease (EMPD) will be collected as part of this registry..	25 years

External Links

•   Mayo Clinic Clinical Trials