Clinical trial NCT03564483: Gynecologic Extramammary Paget's Disease
Official title: Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with Extramammary Paget's Disease

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Collect prospective data including outcomes and long-term survival in women with extramammary Paget's disease (EMPD).
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jamie N. Bakkum-Gamez, M.D.
role: PRINCIPAL_INVESTIGATOR
References: